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Orange Book drug · Generic (ANDA)

Butalbital, Acetaminophen And Caffeine

Acetaminophen; Butalbital; Caffeine

ANDA 040387 Genus
Approved
Jan 31, 2003
Strengths
1
Listed patents
0
Applications
45

What does the FDA Orange Book show for Butalbital, Acetaminophen And Caffeine?

Butalbital, Acetaminophen And Caffeine contains Acetaminophen; Butalbital; Caffeine and appears in 45 FDA Orange Book applications. ANDA 040387 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
45; lead ANDA 040387

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

Lead application holder
Genus Lifesciences Inc

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
None posted

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/15ML;50MG/15ML;40MG/15MLSOLUTIONORALPrescriptionNone posted
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

Genus Lifesciences Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 040387.

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

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

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

7 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 040387 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Oral

Acetaminophen; Butalbital; Caffeine

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-040387

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 040387
RS
Strength
325MG/15ML;50MG/15ML;40MG/15ML
Dosage form
SOLUTION
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    23 yr 10 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Strength

325MG/15ML;50MG/15ML;40MG/15ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

ANDA 040387

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 Butalbital, Acetaminophen And Caffeine

44 additional filings · 44 generic

The FDA has approved 45 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 Butalbital, Acetaminophen And Caffeine, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 040511Strides Pharma IntlAug 27, 20031AAPrescription
ANDA 040885Lgm PharmaNov 16, 20091AAPrescription
ANDA 088616Actavis Labs Ut IncNov 09, 19841AAPrescription
ANDA 088825Gilbert LabsDec 05, 19841—Discontinued
ANDA 089007DR Reddys Labs SaMar 17, 19861AAPrescription
ANDA 040261HikmaOct 28, 19981—Discontinued
ANDA 040267Watson LabsJul 30, 19981—Discontinued
ANDA 040336HikmaAug 18, 19991—Discontinued
ANDA 040390AbleJul 23, 20011—Discontinued
ANDA 040394AbleJul 23, 20011—Discontinued
ANDA 040496MikartDec 23, 20031—Discontinued
ANDA 040513Vintage PharmsAug 25, 20031—Discontinued
ANDA 040601Sun Pharm IndustriesJul 29, 20051—Discontinued
ANDA 040864GranulesDec 01, 20081AAPrescription
ANDA 040883Mirror Pharms LLCDec 23, 20081—Discontinued
ANDA 087629Gilbert LabsNov 13, 19841—Discontinued
ANDA 087804Specgx LLCJan 24, 19851—Discontinued
ANDA 088743Graham DmJul 18, 19851—Discontinued
ANDA 088758MallinckrodtMar 27, 19851—Discontinued
ANDA 088765Graham DmMar 27, 19851—Discontinued
ANDA 089067Graham DmApr 19, 19851—Discontinued
ANDA 089175MikartJan 21, 19871AAPrescription
ANDA 089536Watson LabsFeb 16, 19881—Discontinued
ANDA 089718Hikma PharmsJun 12, 19951—Discontinued
ANDA 200243Lannett Co IncSep 13, 20121AAPrescription
ANDA 203647Strides PharmaSep 21, 20201—Discontinued
ANDA 204733Aurolife Pharma LLCSep 26, 20181AAPrescription
ANDA 204984AlvogenJan 10, 20171—Discontinued
ANDA 206615Key TherapAug 04, 20171—Discontinued
ANDA 207118Nuvo Pharms IncOct 28, 20161AAPrescription
ANDA 209587Lgm PharmaOct 31, 20181AAPrescription
ANDA 210817DR Reddys Labs SaDec 17, 20191AAPrescription
ANDA 211106Abhai LLCSep 26, 20181AAPrescription
ANDA 211543Nesher PharmsJul 17, 20201—Discontinued
ANDA 212082Lannett Co IncDec 17, 20191AAPrescription
ANDA 212083Lannett Co IncDec 17, 20191AAPrescription
ANDA 213046TaroJul 01, 20201AAPrescription
ANDA 213321GranulesApr 08, 20201AAPrescription
ANDA 214087Senores PharmsAug 13, 20212AAPrescription
ANDA 214287QuagenJan 18, 20241AAPrescription
ANDA 214288QuagenFeb 08, 20241AAPrescription
ANDA 215047Ingenus Pharms LLCNov 17, 20211AAPrescription
ANDA 215135HikmaMar 25, 20222—Discontinued
ANDA 216376QuagenMar 12, 20241AAPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Acetaminophen; Butalbital; Caffeine

View full Acetaminophen; Butalbital; Caffeine 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.

Butalbital, Acetaminophen And Caffeine: 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 040387 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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