FDA.reportPublic FDA data

Butalbital, Acetaminophen, Caffeine

Product NDC
68071-2365
Requested package NDC
68071-2365-3
11-digit product format
680712365
Labeler code
68071
Product ID
68071-2365_de1f2d42-17ec-34a4-e053-2995a90a3023
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209587
Marketing category
ANDA
Marketing start
2019-03-05
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage68071-236568071-2365-3IInactivated by FDA2026-07-31

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2365-32025-01-30C16284748780-12cef2736-9cbd-d83d-e063-dadaa90ab31fBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
68071-2365-62025-01-30C16284748780-12cef2736-9cbd-d83d-e063-dadaa90ab31fBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
68071-2365-82025-01-30C16284748780-12cef2736-9cbd-d83d-e063-dadaa90ab31fBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
68071-2365-92025-01-30C16284748780-12cef2736-9cbd-d83d-e063-dadaa90ab31fBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2365-3Butalbital, Acetaminophen, Caffeine30 in 1 BOTTLETABLET, COATED303
68071-2365-6Butalbital, Acetaminophen, Caffeine60 in 1 BOTTLETABLET, COATED603
68071-2365-8Butalbital, Acetaminophen, Caffeine180 in 1 BOTTLETABLET, COATED1803
68071-2365-9Butalbital, Acetaminophen, Caffeine90 in 1 BOTTLETABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2365BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 4 package rows20220824_bd5d031e-e5e2-1671-e053-2995a90a5d5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNbd5d031e-e5e2-1671-e053-2995a90a5d5a3
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDbd5d031e-e5e2-1671-e053-2995a90a5d5a3
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYbd5d031e-e5e2-1671-e053-2995a90a5d5a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2365-36807123650330 TABLET, COATED in 1 BOTTLE (68071-2365-3) 2021-03-120000-00-00NoNoCurrent