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 1.

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1995-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1995-06-123f01610625f2…
2019-09-15 20:21 UTC2019-09A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1995-06-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1995-06-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089718-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORAL1995-06-12f41ea6bd6efb…
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…

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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEMayne Pharmafa88f437-830b-48bc-a44c-fd142963a1502025-01-08Boxed 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
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC8438f08f-a32a-4180-9030-e0fd5da4be302024-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC24813ec6-0111-4782-9182-a2b93501a2bc2024-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepacke9dffed5-d615-4e63-9860-c0f6f23848a12024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEKVK-Tech, Inc.7f9c4668-4f4a-453b-b2fa-a6fed903ddfa2024-02-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack6a593fc7-49b0-4910-8a0c-5e718e5ff45b2024-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESeton Pharmaceuticals LLC3c5cefe3-c84e-4380-97f3-78e3fe92543a2024-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEMikart, LLCa26775c2-cafb-4b13-99ac-d4e8248265fb2024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: butalbital, acetaminophen and caffeine
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGranules Pharmaceuticals Inc.2407efce-b77e-4072-bc4b-62c789d01e1a2023-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackb94ab2bc-6ef3-4a64-ba05-a0a4e37794fa2023-11-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack6e28cc29-a85a-44d0-9c5b-bd0934ece64d2023-11-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC5f3c7457-6670-4a0d-bdff-c3e0fe91b7c62023-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3875c01b-7cd6-4bed-8d4e-c580c55408602023-04-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: butalbital, acetaminophen and caffeine
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGolden State Medical Supply, Inc.ee131bce-863b-b5a1-e053-2a95a90afc792023-03-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGranules Pharmaceuticals Inc.74e27dab-9790-47e4-b4f1-3b9df4bce1842023-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEProficient Rx LP1bde13a5-cdd4-4bc2-8aeb-32e4dc1572932021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: butalbital, acetaminophen and caffeine

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