FDA.reportPublic FDA data

Application 206615

Type
ANDA
Sponsor
WRASER PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORAL300MG;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
A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 41 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 CAFFEINEREMEDYREPACK INC.3c761587-3090-425e-bc83-139c32c9439d2026-05-19Boxed 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 CAFFEINEREMEDYREPACK INC.157fd0d2-aa54-406c-bcdb-dad531de3ce72026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEStrides Pharma Science Limitedac9e0cbf-aca6-4cb6-b63a-c25713c5200d2026-01-09Boxed 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 CAFFEINEGenus Lifesciences Inc.5f603b0d-69e5-4c02-b6b3-b4705e243e9a2025-07-14Boxed 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineXspire Pharma, LLCANDACurrent
42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineXspire Pharma, LLCANDACurrent
42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineXspire Pharma, LLCANDACurrent
42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineXspire Pharma, LLCANDACurrent
66992-955Phrenilin ForteButalbital, Acetaminophen, CaffeineWraser LLCANDACurrent
71205-962Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineProficient Rx LPANDACurrent
71205-962Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineProficient Rx LPANDACurrent