FDA.reportPublic FDA data

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product NDC
71335-2546
11-digit product format
713352546
Labeler code
71335
Product ID
71335-2546_79ce2e93-19de-49dc-b30d-696ec421b030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214287
Marketing category
ANDA
Marketing start
2024-05-01
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
325; 50; 40 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
2026-12-31
Current FDA listing
Yes

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
A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214287-001AA

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
2026-02-19 14:30 UTC2026-02A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-181c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214287-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214287-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214287-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214287-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214287-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214287-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214287-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214287-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214287-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214287-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214287-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214287-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214287-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214287-001AA18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214287-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214287-001AA11c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214287-001AA1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTALBITAL325 mg/1
ACETAMINOPHEN50 mg/1
CAFFEINE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KHS0AZ4JVKInternal UNII lookup
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238154Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9df47cf-f999-49d8-95b9-374c0539b6a1Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2546-0BUTALBITAL, ACETAMINOPHEN AND CAFFEINE84 in 1 BOTTLE, PLASTICTABLET841
71335-2546-1BUTALBITAL, ACETAMINOPHEN AND CAFFEINE20 in 1 BOTTLE, PLASTICTABLET201
71335-2546-2BUTALBITAL, ACETAMINOPHEN AND CAFFEINE30 in 1 BOTTLE, PLASTICTABLET301
71335-2546-3BUTALBITAL, ACETAMINOPHEN AND CAFFEINE60 in 1 BOTTLE, PLASTICTABLET601
71335-2546-4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE90 in 1 BOTTLE, PLASTICTABLET901
71335-2546-5BUTALBITAL, ACETAMINOPHEN AND CAFFEINE50 in 1 BOTTLE, PLASTICTABLET501
71335-2546-6BUTALBITAL, ACETAMINOPHEN AND CAFFEINE6 in 1 BOTTLE, PLASTICTABLET61
71335-2546-7BUTALBITAL, ACETAMINOPHEN AND CAFFEINE120 in 1 BOTTLE, PLASTICTABLET1201
71335-2546-8BUTALBITAL, ACETAMINOPHEN AND CAFFEINE40 in 1 BOTTLE, PLASTICTABLET401
71335-2546-9BUTALBITAL, ACETAMINOPHEN AND CAFFEINE12 in 1 BOTTLE, PLASTICTABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2546-2EA - Each71335-2546b817ccd5-69d6-4f03-b5fc-16b1471b3af112025-08-11
71335-2546-3EA - Each71335-254629e06862-204b-4a2e-aa2a-30971b04bf0b12025-12-16
71335-2546-4EA - Each71335-2546c2267136-c039-45e9-af1b-b3603fa1bcc412025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2546BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [BRYANT RANCH PREPACK]1Current NDC, 10 package rows20250119_b9df47cf-f999-49d8-95b9-374c0539b6a1.zip

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 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackf6bd2076-869e-40de-94ce-6be43d50f6802026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEREMEDYREPACK INC.3c761587-3090-425e-bc83-139c32c9439d2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAdvanced Rx of Tennessee, LLC45a18fad-ad4e-3a1b-e063-6394a90a23cf2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack2eefa0ac-70f6-43ab-b59e-c4ecad853fe72025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackb9df47cf-f999-49d8-95b9-374c0539b6a12025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
ndc (product): 71335-2546
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEPreferred Pharmaceuticals Inc.91e50642-d278-47c6-944b-4ed907e87e6b2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC24813ec6-0111-4782-9182-a2b93501a2bc2024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNb9df47cf-f999-49d8-95b9-374c0539b6a11
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDb9df47cf-f999-49d8-95b9-374c0539b6a11
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYb9df47cf-f999-49d8-95b9-374c0539b6a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2546-07133525460084 TABLET in 1 BOTTLE, PLASTIC (71335-2546-0) 84 tablet2025-01-17NoNoCurrent
71335-2546-17133525460120 TABLET in 1 BOTTLE, PLASTIC (71335-2546-1) 20 tablet2025-01-17NoNoCurrent
71335-2546-27133525460230 TABLET in 1 BOTTLE, PLASTIC (71335-2546-2) 30 tablet2025-01-17NoNoCurrent
71335-2546-37133525460360 TABLET in 1 BOTTLE, PLASTIC (71335-2546-3) 60 tablet2025-01-17NoNoCurrent
71335-2546-47133525460490 TABLET in 1 BOTTLE, PLASTIC (71335-2546-4) 90 tablet2025-01-17NoNoCurrent
71335-2546-57133525460550 TABLET in 1 BOTTLE, PLASTIC (71335-2546-5) 50 tablet2025-01-17NoNoCurrent
71335-2546-6713352546066 TABLET in 1 BOTTLE, PLASTIC (71335-2546-6) 6 tablet2025-01-17NoNoCurrent
71335-2546-771335254607120 TABLET in 1 BOTTLE, PLASTIC (71335-2546-7) 120 tablet2025-01-17NoNoCurrent
71335-2546-87133525460840 TABLET in 1 BOTTLE, PLASTIC (71335-2546-8) 40 tablet2025-01-17NoNoCurrent
71335-2546-97133525460912 TABLET in 1 BOTTLE, PLASTIC (71335-2546-9) 12 tablet2025-01-17NoNoCurrent