FDA.reportPublic FDA data

Butalbital, Acetaminophen, Caffeine

Product NDC
70518-2995
Requested package NDC
70518-2995-1
11-digit product format
705182995
Labeler code
70518
Product ID
70518-2995_c10930fb-a6ab-077e-e053-2a95a90a51d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209587
Marketing category
ANDA
Marketing start
2021-01-19
Marketing end
0000-00-00
Substance
BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength
50 mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-299570518-2995-1DDiscontinued by firm2026-07-31

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
A209587-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE325MG;50MG;40MGTABLET / ORALAA2018-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A209587-001AA

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 22:54:322026-06A209587-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2018-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209587-001AA1a50c72e98297…

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEHAWAII REPACK, INC.ab882f60-394c-4d4f-95f4-6b9d6d6b31932026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEPreferred Pharmaceuticals Inc.b121190e-db2a-43bb-a57d-b6683a9e20592026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAdvanced Rx of Tennessee, LLC4871c36f-229b-4c12-e063-6394a90a028e2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEREMEDYREPACK INC.dc2bb7fc-1722-4865-a02c-be5e5c2115052026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAsclemed USA, Inc.cce09e09-158f-4927-8a3e-4ec9334f0b7a2025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
BUTAL/APAP/CAFFEINEBUTAL/APAP/CAFFEINEDirect_Rx2abb9915-edb2-6218-e063-6394a90ad4622025-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAvPAKe5fbd6b8-85e7-8847-e053-2a95a90a52ed2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEProficient Rx LP3cf799b4-c785-4ae2-908b-c42e426733dc2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEBryant Ranch Prepacke2978345-826a-47d2-acf3-feb6afb1967e2024-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINELGM PHARMA SOLUTIONS, LLCf6548126-faa1-4f53-8e0b-bc1b743de04d2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEA-S Medication Solutionsf822c103-b678-4e76-8174-33b94421dd1e2024-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEProficient Rx LPd860af16-fab4-4263-9e66-a648d5e81dab2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEBryant Ranch Prepack90e166ac-8789-4e7a-b5bb-37c475e3a5b02023-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEWestminster Pharmaceuticals, LLC1c0511d0-fe63-45c6-8da2-6ceeb56edb172019-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209587
application number: ANDA209587

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2995-02025-11-27C16284748780-1f386c64a-02e4-0266-e053-dadaa90a7c1aBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
70518-2995-12025-11-27C16284748780-1f386c64a-02e4-0266-e053-dadaa90a7c1aBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
70518-2995-02025-01-30C16284748780-1f386c64a-02e4-0266-e053-dadaa90a7c1aBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
70518-2995-12025-01-30C16284748780-1f386c64a-02e4-0266-e053-dadaa90a7c1aBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
70518-2995-02023-03-24C16284748780-1f386c64a-02e4-0266-e053-dadaa90a7c1aBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
70518-2995-12023-03-24C16284748780-1f386c64a-02e4-0266-e053-dadaa90a7c1aBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
70518-2995-02023-01-30C16284748780-1f386c64a-02e4-0266-e053-dadaa90a7c1aBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
70518-2995-12023-01-30C16284748780-1f386c64a-02e4-0266-e053-dadaa90a7c1aBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2995BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET, COATED [REMEDYREPACK INC.]3Legacy NDC20230324_f6c45ff5-cab8-44f0-8079-7fe92083a61e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2995-17051829950160 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2995-1) 2021-04-280000-00-00NoNoCurrent