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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
BUTALBITAL50 mg/1
CAFFEINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E
Rxcui238154

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

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 tablet2025-01-17NoNoHistorical
71335-2546-17133525460120 TABLET in 1 BOTTLE, PLASTIC (71335-2546-1) 20 tablet2025-01-17NoNoHistorical
71335-2546-27133525460230 TABLET in 1 BOTTLE, PLASTIC (71335-2546-2) 30 tablet2025-01-17NoNoHistorical
71335-2546-37133525460360 TABLET in 1 BOTTLE, PLASTIC (71335-2546-3) 60 tablet2025-01-17NoNoHistorical
71335-2546-47133525460490 TABLET in 1 BOTTLE, PLASTIC (71335-2546-4) 90 tablet2025-01-17NoNoHistorical
71335-2546-57133525460550 TABLET in 1 BOTTLE, PLASTIC (71335-2546-5) 50 tablet2025-01-17NoNoHistorical
71335-2546-6713352546066 TABLET in 1 BOTTLE, PLASTIC (71335-2546-6) 6 tablet2025-01-17NoNoHistorical
71335-2546-771335254607120 TABLET in 1 BOTTLE, PLASTIC (71335-2546-7) 120 tablet2025-01-17NoNoHistorical
71335-2546-87133525460840 TABLET in 1 BOTTLE, PLASTIC (71335-2546-8) 40 tablet2025-01-17NoNoHistorical
71335-2546-97133525460912 TABLET in 1 BOTTLE, PLASTIC (71335-2546-9) 12 tablet2025-01-17NoNoHistorical