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Orange Book drug · Generic (ANDA)

Acetaminophen And Codeine Phosphate

Acetaminophen; Codeine Phosphate

ANDA 040419 3 strengths Specgx LLC
Approved
May 31, 2001
Strengths
3
Listed patents
0
Applications
89

What does the FDA Orange Book show for Acetaminophen And Codeine Phosphate?

Acetaminophen And Codeine Phosphate contains Acetaminophen; Codeine Phosphate and appears in 89 FDA Orange Book applications. ANDA 040419 is the lead filing, with 3 presentations 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
89; lead ANDA 040419

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
3

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
001300MG;15MGTABLETORALPrescriptionAA
RS
002300MG;30MGTABLETORALPrescriptionAA
RS
003300MG;60MGTABLETORALPrescriptionAA
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 040419.

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

3 presentations 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

19 other ANDAs and 0 other NDAs found

0 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 040419 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-040419

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.

Strengths & dosage forms

3 approved presentations · ANDA 040419
TE AARS
Strength
300MG;15MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    25 yr 6 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Strength

300MG;15MG

Dosage form

TABLET

Route

ORAL

TE code

AA

Application

ANDA 040419

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 Acetaminophen And Codeine Phosphate

88 additional filings · 88 generic

The FDA has approved 89 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 Acetaminophen And Codeine Phosphate, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 085861Actavis Mid AtlanticApproved Prior to Jan 1, 19821—Discontinued
ANDA 085917SandozApproved Prior to Jan 1, 19821—Discontinued
ANDA 086681Purepac PharmApproved Prior to Jan 1, 19821—Discontinued
ANDA 087433SandozApproved Prior to Jan 1, 19821—Discontinued
ANDA 087508Genus LifesciencesApproved Prior to Jan 1, 19821—Prescription
ANDA 088629Ani PharmsMar 06, 19853—Discontinued
ANDA 040098Dava Pharms IncSep 20, 19961—Discontinued
ANDA 040119Pai HoldingsApr 26, 19961—Discontinued
ANDA 040223Duramed Pharms BarrNov 18, 19973—Discontinued
ANDA 040443Watson Labs FloridaJan 22, 20033—Discontinued
ANDA 040452AbleAug 01, 20021—Discontinued
ANDA 040459AbleAug 01, 20021—Discontinued
ANDA 040779Amneal Pharms NyMay 29, 20081AAPrescription
ANDA 081249Fosun PharmaJul 16, 19921—Discontinued
ANDA 081250Fosun PharmaJul 16, 19921—Discontinued
ANDA 083871HalseyApproved Prior to Jan 1, 19821—Discontinued
ANDA 083872HalseyApproved Prior to Jan 1, 19821—Discontinued
ANDA 084360Whiteworth Town PlsnApproved Prior to Jan 1, 19821—Discontinued
ANDA 084656RoxaneApproved Prior to Jan 1, 19821—Discontinued
ANDA 084659RoxaneApproved Prior to Jan 1, 19821—Discontinued
ANDA 084667RoxaneApproved Prior to Jan 1, 19821—Discontinued
ANDA 085217EverylifeApproved Prior to Jan 1, 19821—Discontinued
ANDA 085218Warner ChilcottApproved Prior to Jan 1, 19821—Discontinued
ANDA 085288Kv PharmApproved Prior to Jan 1, 19821—Discontinued
ANDA 085291SandozApproved Prior to Jan 1, 19821—Discontinued
ANDA 085363Kv PharmApproved Prior to Jan 1, 19821—Discontinued
ANDA 085364Kv PharmApproved Prior to Jan 1, 19821—Discontinued
ANDA 085365Kv PharmApproved Prior to Jan 1, 19821—Discontinued
ANDA 085607Whiteworth Town PlsnApproved Prior to Jan 1, 19821—Discontinued
ANDA 085676VitarineApproved Prior to Jan 1, 19821—Discontinued
ANDA 085794Mutual PharmApproved Prior to Jan 1, 19821—Discontinued
ANDA 085795Mutual PharmApproved Prior to Jan 1, 19821—Discontinued
ANDA 085868Sun Pharm Inds LtdApproved Prior to Jan 1, 19821—Discontinued
ANDA 085896Valeant Pharm IntlApproved Prior to Jan 1, 19821—Discontinued
ANDA 085964SandozApproved Prior to Jan 1, 19821—Discontinued
ANDA 085992Warner ChilcottApproved Prior to Jan 1, 19821—Discontinued
ANDA 086366Strides PharmaApproved Prior to Jan 1, 19821—Discontinued
ANDA 086549HalseyApproved Prior to Jan 1, 19821—Discontinued
ANDA 086683Purepac PharmApproved Prior to Jan 1, 19821—Discontinued
ANDA 087006PharmobedientApproved Prior to Jan 1, 19821—Discontinued
ANDA 087083Sun Pharm Inds LtdApproved Prior to Jan 1, 19821AAPrescription
ANDA 087141LederleApproved Prior to Jan 1, 19821—Discontinued
ANDA 087275Watson LabsMay 26, 19821—Discontinued
ANDA 087276Watson LabsMay 26, 19821—Discontinued
ANDA 087277Watson LabsMay 26, 19821—Discontinued
ANDA 087306Warner ChilcottApproved Prior to Jan 1, 19821—Discontinued
ANDA 087423SandozApproved Prior to Jan 1, 19821—Discontinued
ANDA 087653Mutual PharmApr 13, 19821—Discontinued
ANDA 087762Puracap PharmDec 10, 19821—Discontinued
ANDA 087919Usl PharmaJun 22, 19821—Discontinued
ANDA 087920Usl PharmaJun 22, 19821—Discontinued
ANDA 088324TevaDec 29, 19831—Discontinued
ANDA 088353Duramed Pharms BarrFeb 06, 19841—Discontinued
ANDA 088354Duramed Pharms BarrFeb 06, 19841—Discontinued
ANDA 088355Duramed Pharms BarrFeb 06, 19841—Discontinued
ANDA 088537TevaJun 04, 19841—Discontinued
ANDA 088599TevaJun 01, 19841—Discontinued
ANDA 089080Purepac PharmJul 17, 19861—Discontinued
ANDA 089183SuperpharmOct 18, 19851—Discontinued
ANDA 089184SuperpharmOct 18, 19851—Discontinued
ANDA 089185SuperpharmOct 18, 19851—Discontinued
ANDA 089231MikartMar 03, 19861—Discontinued
ANDA 089238MikartFeb 25, 19861—Discontinued
ANDA 089244MikartFeb 25, 19861—Discontinued
ANDA 089253SuperpharmMay 19, 19861—Discontinued
ANDA 089254SuperpharmMay 19, 19861—Discontinued
ANDA 089363MikartSep 09, 19911—Discontinued
ANDA 089450ChartwellOct 27, 19921—Discontinued
ANDA 089478Am TherapMar 03, 19871—Discontinued
ANDA 089479Am TherapMar 03, 19871—Discontinued
ANDA 089480Am TherapMar 03, 19871—Discontinued
ANDA 089481Am TherapMar 03, 19871—Discontinued
ANDA 089482Am TherapMar 03, 19871—Discontinued
ANDA 089483Am TherapMar 03, 19871—Discontinued
ANDA 089511RoxaneApr 25, 19891—Discontinued
ANDA 089512RoxaneApr 25, 19891—Discontinued
ANDA 089513RoxaneApr 25, 19891—Discontinued
ANDA 089673Rhodes PharmsFeb 10, 19883—Discontinued
ANDA 089805Strides Pharma IntlSep 30, 19881AAPrescription
ANDA 089828Strides Pharma IntlSep 30, 19881AAPrescription
ANDA 089990Strides Pharma IntlSep 30, 19881AAPrescription
ANDA 089997ChartwellDec 28, 19941—Discontinued
ANDA 089998ChartwellDec 28, 19941—Discontinued
ANDA 089999ChartwellDec 28, 19941—Discontinued
ANDA 091238Chartwell MolecularNov 10, 20111—Discontinued
ANDA 202800Aurolife Pharma LLCApr 15, 20133AAPrescription
ANDA 211610Hibrow HlthcareJun 27, 20193AAPrescription
ANDA 212418Elite Labs IncSep 10, 20193AAPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Acetaminophen; Codeine Phosphate

View full Acetaminophen; Codeine Phosphate 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.

Acetaminophen And Codeine Phosphate: 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 040419 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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