FDA.reportPublic FDA data

Application 076528

Type
ANDA
Sponsor
ABLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORAL325MG;50MG;40MG;30MGNoNo
002BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINEBUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATECapsule; Oral40MG/30MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076528-001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORAL2003-08-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A076528-001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORAL2003-08-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076528-001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORAL2003-08-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076528-001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORAL2003-08-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076528-001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORAL2003-08-21a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEBryant Ranch Prepack15a34df5-e48f-4570-9232-80e4093c46242026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEHikma Pharmaceuticals USA Inc.6e0e8abc-512b-42f7-8323-434c589edecf2026-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEBreckenridge Pharmaceutical, Inc.d74db417-d2de-495b-bb75-46a83745603d2024-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEBryant Ranch Prepack215e2a6f-ec32-4836-8fad-22c8b40ba1f12024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.