FDA.reportPublic FDA data

Butalbital, Acetaminophen, Caffeine

Product NDC
68788-7882
Requested package NDC
68788-7882-3
11-digit product format
687887882
Labeler code
68788
Product ID
68788-7882_b3febdde-f352-4627-ba59-96a10f6ac8aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209587
Marketing category
ANDA
Marketing start
2021-03-10
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 packagepackage68788-788268788-7882-3DDiscontinued 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7882-1EA - Each68788-7882c965c49f-c394-4e51-a478-f534b041e76012021-04-08
68788-7882-2EA - Each68788-7882e5b2618c-9ae9-4499-8c00-77198fe03fa512021-04-08
68788-7882-3EA - Each68788-7882810dea01-c6d9-4690-9f3d-10eb2d906ea112021-04-08
68788-7882-6EA - Each68788-78824901b0f5-126e-4bf2-8bff-6edcdb1d659b12021-04-08
68788-7882-8EA - Each68788-788271295182-88a3-4886-8878-6196f840c3fb12021-04-08
68788-7882-9EA - Each68788-7882a8c5aced-d97a-4e26-baad-b7c755087cd212021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7882-36878878820330 TABLET, COATED in 1 BOTTLE (68788-7882-3) 2021-03-100000-00-00NoNoCurrent