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Orange Book drug · Generic (ANDA)

Hydrocodone Bitartrate And Acetaminophen

Acetaminophen; Hydrocodone Bitartrate

ANDA 040400 Specgx LLC
Approved
Jul 26, 2000
Strengths
1
Listed patents
0
Applications
126

What does the FDA Orange Book show for Hydrocodone Bitartrate And Acetaminophen?

Hydrocodone Bitartrate And Acetaminophen contains Acetaminophen; Hydrocodone Bitartrate and appears in 126 FDA Orange Book applications. ANDA 040400 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
126; lead ANDA 040400

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Specgx LLC

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
AA

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
0

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001325MG;10MGTABLETORALPrescriptionAA
RS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Specgx LLC

The Orange Book identifies this organization as the applicant responsible for ANDA 040400.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AA across rated presentations

An AA code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

No listed patents or exclusivity records

This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.

Same-ingredient landscape

24 other ANDAs and 0 other NDAs found

2 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

ANDA 040400 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Acetaminophen; Hydrocodone Bitartrate

121 applications
Product rows
221
Active applications
21
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-040400

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

ANDA 040400
TE AARS
Strength
325MG;10MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    26 yr 5 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Strength

325MG;10MG

Dosage form

TABLET

Route

ORAL

TE code

AA

Application

ANDA 040400

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Other FDA applications for Hydrocodone Bitartrate And Acetaminophen

125 additional filings · 125 generic

The FDA has approved 126 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Hydrocodone Bitartrate And Acetaminophen, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 040834Pharm AssocApr 18, 20081—Prescription
ANDA 040881MikartFeb 25, 20101—Prescription
ANDA 206718Specgx LLCMar 31, 20173AAPrescription
ANDA 211023Wes Pharma IncMar 08, 20191AAPrescription
ANDA 211487Ascent Pharms IncNov 07, 20184AAPrescription
ANDA 040084MallinckrodtJun 01, 19954—Discontinued
ANDA 040094Watson LabsSep 29, 19954—Discontinued
ANDA 040122Watson LabsMar 04, 19962—Discontinued
ANDA 040123Watson LabsMar 04, 19964—Discontinued
ANDA 040134Ucb IncNov 21, 19961—Discontinued
ANDA 040143Vintage PharmsFeb 22, 19961—Discontinued
ANDA 040144Vintage PharmsApr 25, 19972—Discontinued
ANDA 040148ApilFeb 14, 19971—Discontinued
ANDA 040149SandozJan 27, 19972—Discontinued
ANDA 040155Vintage PharmsApr 14, 19971—Discontinued
ANDA 040157Vintage PharmsApr 12, 19961—Discontinued
ANDA 040182Pharm AssocMar 13, 19981—Discontinued
ANDA 040201MallinckrodtFeb 27, 19982—Discontinued
ANDA 040210Ucb IncAug 13, 19971—Discontinued
ANDA 040236Mutual PharmSep 25, 19972—Discontinued
ANDA 040240Mutual PharmNov 26, 19972—Discontinued
ANDA 040248ChartwellApr 28, 20002—Discontinued
ANDA 040280Vintage Pharms LLCSep 30, 19983—Discontinued
ANDA 040281Vintage Pharms LLCSep 30, 19982—Discontinued
ANDA 040307BarrJul 26, 20004—Discontinued
ANDA 040308BarrJul 26, 20002—Discontinued
ANDA 040309BarrJul 26, 20001—Discontinued
ANDA 040355Strides Pharma IntlMay 31, 20001—Discontinued
ANDA 040356Vintage PharmsMay 31, 20001—Discontinued
ANDA 040358Vintage PharmsMay 31, 20001—Discontinued
ANDA 040366Nesher PharmsJan 23, 20021—Discontinued
ANDA 040418MallinckrodtJun 27, 20011—Discontinued
ANDA 040432ChartwellJan 22, 20031—Discontinued
ANDA 040464AbleOct 23, 20022—Discontinued
ANDA 040469AbleOct 25, 20021—Discontinued
ANDA 040473AbleNov 06, 20021—Discontinued
ANDA 040474AbleJan 02, 20031—Discontinued
ANDA 040476AbleOct 23, 20021—Discontinued
ANDA 040477AbleNov 06, 20021—Discontinued
ANDA 040478AbleNov 08, 20021—Discontinued
ANDA 040482ChartwellSep 25, 20031—Discontinued
ANDA 040490AbleMay 21, 20031—Discontinued
ANDA 040493Watson Labs FloridaMay 28, 20031—Discontinued
ANDA 040494Watson Labs FloridaMay 28, 20031—Discontinued
ANDA 040495Watson Labs FloridaMay 28, 20031—Discontinued
ANDA 040508Mallinckrodt IncAug 29, 20031—Discontinued
ANDA 040520Vintage PharmsOct 30, 20031—Discontinued
ANDA 040655Strides Pharma IntlJan 19, 20061—Discontinued
ANDA 040656Strides Pharma IntlJan 19, 20061—Discontinued
ANDA 040658ChartwellJan 19, 20063—Discontinued
ANDA 040729Amneal Pharms NyAug 25, 20061—Discontinued
ANDA 040736Amneal Pharms NyAug 25, 20061AAPrescription
ANDA 040746Amneal Pharms NyMay 10, 20162AAPrescription
ANDA 040748Amneal Pharms NyAug 25, 20061—Discontinued
ANDA 040754Amneal Pharms NyAug 25, 20061—Discontinued
ANDA 040757Amneal Pharms NyAug 25, 20061—Discontinued
ANDA 040769Amneal Pharms NyAug 28, 20061—Discontinued
ANDA 040813Amneal Pharms NyFeb 23, 20071—Discontinued
ANDA 040822Ranbaxy Labs LtdAug 16, 20071—Discontinued
ANDA 040824RanbaxyAug 16, 20071—Discontinued
ANDA 040825RanbaxyAug 16, 20071—Discontinued
ANDA 040826Sun Pharm Inds LtdAug 16, 20071—Discontinued
ANDA 040838Pharm AssocMay 10, 20131AAPrescription
ANDA 040846MikartJun 09, 20101—Discontinued
ANDA 040849MikartJun 09, 20101—Discontinued
ANDA 040894GenusJul 19, 20111AAPrescription
ANDA 081051MikartAug 28, 19921—Discontinued
ANDA 081067MikartNov 30, 19891—Discontinued
ANDA 081068MikartNov 30, 19891—Discontinued
ANDA 081069MikartNov 30, 19891—Discontinued
ANDA 081070MikartNov 30, 19891—Discontinued
ANDA 081079Watson LabsAug 30, 19911—Discontinued
ANDA 081080Watson LabsAug 30, 19911—Discontinued
ANDA 081083Watson LabsAug 30, 19911—Discontinued
ANDA 081223MikartMay 29, 19921—Discontinued
ANDA 081226MikartOct 27, 19921—Discontinued
ANDA 088577BarrDec 21, 19841—Discontinued
ANDA 088956MallinckrodtJul 19, 19851—Discontinued
ANDA 089006MallinckrodtAug 09, 19851—Discontinued
ANDA 089008MikartFeb 21, 19861—Discontinued
ANDA 089271MikartJul 16, 19861—Discontinued
ANDA 089290Usl PharmaMay 29, 19871—Discontinued
ANDA 089291Usl PharmaMay 29, 19871—Discontinued
ANDA 089554HalseyJun 12, 19871—Discontinued
ANDA 089557MikartApr 29, 19921—Discontinued
ANDA 089689MikartJun 29, 19881—Discontinued
ANDA 089696Ivax PharmsApr 21, 19881—Discontinued
ANDA 089697MikartJan 28, 19921—Discontinued
ANDA 089698MikartAug 25, 19891—Discontinued
ANDA 089699MikartAug 25, 19891—Discontinued
ANDA 089831Vintage PharmsSep 07, 19881—Discontinued
ANDA 089883Watson LabsDec 01, 19881—Discontinued
ANDA 089971Vintage PharmsDec 02, 19881—Discontinued
ANDA 090118Sun Pharm Inds IncDec 23, 20083—Discontinued
ANDA 090265CaracoDec 23, 20083—Discontinued
ANDA 090380CaracoDec 23, 20084—Discontinued
ANDA 090415Ph HealthJan 24, 20113—Discontinued
ANDA 200343GenusJan 25, 20121—Discontinued
ANDA 201013Aurolife Pharma LLCApr 11, 20123AAPrescription
ANDA 201295Tris Pharma IncDec 30, 20212—Discontinued
ANDA 202214Tris Pharma IncMar 15, 20166AAPrescription
ANDA 202935Strides Pharma IntlJun 15, 20163AAPrescription
ANDA 202991Rhodes PharmsApr 12, 20163AAPrescription
ANDA 203863Epic Pharma LLCMar 30, 20183AAPrescription
ANDA 205001Strides Pharma IntlJul 05, 20163—Discontinued
ANDA 206142Novel Labs IncNov 14, 20163—Discontinued
ANDA 206245Novel Labs IncDec 01, 20163—Discontinued
ANDA 206470Actavis Labs Fl IncJun 02, 20163—Discontinued
ANDA 206484Upsher Smith LabsMar 24, 20173—Discontinued
ANDA 206869Amneal Pharms NyJun 23, 20171—Discontinued
ANDA 207137Amneal PharmsNov 29, 20161—Discontinued
ANDA 207171Lannett Co IncJun 20, 20173AAPrescription
ANDA 207172Lannett Co IncJun 22, 20173AAPrescription
ANDA 207509Hibrow HlthcareOct 29, 20183AAPrescription
ANDA 207709Aurolife Pharma LLCSep 13, 20183AAPrescription
ANDA 207808Rhodes PharmsMar 30, 20183—Discontinued
ANDA 208540AlvogenNov 08, 20183—Discontinued
ANDA 209036Abhai LLCJun 21, 20173AAPrescription
ANDA 209037Abhai LLCJun 21, 20173AAPrescription
ANDA 209924Elite Labs IncNov 16, 20184AAPrescription
ANDA 209958AlvogenOct 24, 20184—Discontinued
ANDA 210211Wes Pharma IncOct 30, 20173AAPrescription
ANDA 211690SanaluzFeb 07, 20203—Discontinued
ANDA 211729GranulesJan 03, 20203AAPrescription
ANDA 214928Prinston IncDec 30, 20213—Discontinued

Active-ingredient family

Brand + generics

Generic (ANDA) of Acetaminophen; Hydrocodone Bitartrate

View full Acetaminophen; Hydrocodone Bitartrate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Hydrocodone Bitartrate And Acetaminophen: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of ANDA 040400 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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