FDA.reportPublic FDA data

Application 089718

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINETABLET;ORAL325MG;50MG;40MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A089718-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A089718-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A089718-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089718-001AA1ea99ee380514…

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINESun Pharmaceutical Industries, Inc.a68de112-f5af-49ba-a8a8-3adbaa7df36e2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackf6bd2076-869e-40de-94ce-6be43d50f6802026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack8a4cf981-37f7-4bc9-a9d7-b134a5fd08942026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEPreferred Pharmaceuticals Inc.65fa9aca-ef3d-4bc6-a107-72e6eb5ce2242026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAmici Pharma, Inc.fb12459c-82f8-43d2-8c05-a4b6d4a3e9482026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINERedpharm Drug4727e806-102a-3a28-e063-6294a90ab6e92025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAdvanced Rx of Tennessee, LLC45a18fad-ad4e-3a1b-e063-6394a90a23cf2025-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEChartwell RX, LLC77776146-c6e6-478c-b30e-2b729e7584002025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack2eefa0ac-70f6-43ab-b59e-c4ecad853fe72025-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEST. MARY'S MEDICAL PARK PHARMACY36229f70-aa73-b112-e063-6394a90a5b492025-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAurolife Pharma, LLCf9fde75d-7def-48fc-a2b0-727f677f60012025-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEA-S Medication Solutions21a148d1-b242-4414-82b2-cb78387d7d0f2025-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack03475828-eae2-49ed-a1c0-8074f35c712d2025-03-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAdvanced Rx of Tennessee, LLC2e20e0ee-dd73-6287-e063-6294a90a03b12025-02-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackb9df47cf-f999-49d8-95b9-374c0539b6a12025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESUNRISE PHARMACEUTICAL, INCee7630f8-f4b8-4eb0-b34d-d908567030c42025-01-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3fe91e9f-4033-4b48-b51b-7eb67d40fa3a2024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEPreferred Pharmaceuticals Inc.91e50642-d278-47c6-944b-4ed907e87e6b2024-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESOLCO HEALTHCARE US, LLC5c9c3407-212a-4ae9-a574-2b0c53f3c5eb2024-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEDr. Reddy's Labratories Inc.69df02fa-c842-48dc-7ac6-5967b7dc30de2024-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: butalbital, acetaminophen and caffeine

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineWest-Ward Pharmaceuticals CorpANDACurrent
0143-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineHikma Pharmaceuticals USA Inc.ANDACurrent
0904-6538Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineMajor PharmaceuticalsANDACurrent
0904-6538Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineMajor PharmaceuticalsANDACurrent
17856-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAtlantic Biologicals CorpsANDACurrent
21695-209Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineRebel Distributors CorpANDACurrent
43063-369Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeinePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2105Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineA-S Medication SolutionsANDACurrent
50090-2105Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineA-S Medication SolutionsANDACurrent
50268-139Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAvPAKANDACurrent
55154-7988Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineCardinal HealthANDACurrent
68788-9025Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeinePreferred Pharmaceuticals, Inc.ANDACurrent