FDA.reportPublic FDA data

Butalbital, Acetaminophen and Caffeine

Product NDC
71335-9603
11-digit product format
713359603
Labeler code
71335
Product ID
71335-9603_9cd0d6ab-cb53-47bd-9417-0ad88c4571a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211106
Marketing category
ANDA
Marketing start
2018-09-26
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
71335-9603-0Butalbital, Acetaminophen and Caffeine84 in 1 BOTTLETABLET84102
71335-9603-1Butalbital, Acetaminophen and Caffeine20 in 1 BOTTLETABLET20102
71335-9603-2Butalbital, Acetaminophen and Caffeine30 in 1 BOTTLETABLET30102
71335-9603-3Butalbital, Acetaminophen and Caffeine60 in 1 BOTTLETABLET60102
71335-9603-4Butalbital, Acetaminophen and Caffeine90 in 1 BOTTLETABLET90102
71335-9603-5Butalbital, Acetaminophen and Caffeine50 in 1 BOTTLETABLET50102
71335-9603-6Butalbital, Acetaminophen and Caffeine6 in 1 BOTTLETABLET6102
71335-9603-7Butalbital, Acetaminophen and Caffeine120 in 1 BOTTLETABLET120102
71335-9603-8Butalbital, Acetaminophen and Caffeine40 in 1 BOTTLETABLET40102
71335-9603-9Butalbital, Acetaminophen and Caffeine12 in 1 BOTTLETABLET12102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9603BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20240413_e9dffed5-d615-4e63-9860-c0f6f23848a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNe9dffed5-d615-4e63-9860-c0f6f23848a1102
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDe9dffed5-d615-4e63-9860-c0f6f23848a1102
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYe9dffed5-d615-4e63-9860-c0f6f23848a1102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-9603-07133596030084 TABLET in 1 BOTTLE (71335-9603-0) 84 tablet2022-12-070000-00-00NoNoCurrent
71335-9603-17133596030120 TABLET in 1 BOTTLE (71335-9603-1) 20 tablet2023-02-140000-00-00NoNoCurrent
71335-9603-27133596030230 TABLET in 1 BOTTLE (71335-9603-2) 30 tablet2022-12-070000-00-00NoNoCurrent
71335-9603-37133596030360 TABLET in 1 BOTTLE (71335-9603-3) 60 tablet2024-04-030000-00-00NoNoCurrent
71335-9603-47133596030490 TABLET in 1 BOTTLE (71335-9603-4) 90 tablet2024-04-030000-00-00NoNoCurrent
71335-9603-57133596030550 TABLET in 1 BOTTLE (71335-9603-5) 50 tablet2024-04-030000-00-00NoNoCurrent
71335-9603-6713359603066 TABLET in 1 BOTTLE (71335-9603-6) 6 tablet2024-04-030000-00-00NoNoCurrent
71335-9603-771335960307120 TABLET in 1 BOTTLE (71335-9603-7) 120 tablet2024-04-030000-00-00NoNoCurrent
71335-9603-87133596030840 TABLET in 1 BOTTLE (71335-9603-8) 40 tablet2024-04-030000-00-00NoNoCurrent
71335-9603-97133596030912 TABLET in 1 BOTTLE (71335-9603-9) 12 tablet2024-04-030000-00-00NoNoCurrent