FDA.reportPublic FDA data

Butalbital, Acetaminophen, and Caffeine

Product NDC
71335-0365
11-digit product format
713350365
Labeler code
71335
Product ID
71335-0365_65bc1e24-0409-45ad-8b57-afc73e215114
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200243
Marketing category
ANDA
Marketing start
2012-09-13
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

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
71335-0365-02024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-12024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-22024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-32024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-42024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-52024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-62024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-72024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-82024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-92024-01-30C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-02020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-12020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-22020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-32020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-42020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-52020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-62020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-72020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-82020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-92020-02-03C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-02020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-12020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-22020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-32020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-42020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-52020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-62020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-72020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-82020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-92020-01-31C16284748780-19d75b9d0-7e94-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0365-0Butalbital, Acetaminophen, and Caffeine84 in 1 BOTTLETABLET846
71335-0365-1Butalbital, Acetaminophen, and Caffeine20 in 1 BOTTLETABLET206
71335-0365-2Butalbital, Acetaminophen, and Caffeine30 in 1 BOTTLETABLET306
71335-0365-3Butalbital, Acetaminophen, and Caffeine60 in 1 BOTTLETABLET606
71335-0365-4Butalbital, Acetaminophen, and Caffeine90 in 1 BOTTLETABLET906
71335-0365-5Butalbital, Acetaminophen, and Caffeine50 in 1 BOTTLETABLET506
71335-0365-6Butalbital, Acetaminophen, and Caffeine6 in 1 BOTTLETABLET66
71335-0365-7Butalbital, Acetaminophen, and Caffeine120 in 1 BOTTLETABLET1206
71335-0365-8Butalbital, Acetaminophen, and Caffeine40 in 1 BOTTLETABLET406
71335-0365-9Butalbital, Acetaminophen, and Caffeine12 in 1 BOTTLETABLET126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0365-0EA - Each71335-0365fcad0810-10cf-4785-821a-f2147a8ba61012018-01-12
71335-0365-1EA - Each71335-0365636009c2-f034-4c29-bcd4-a70fe421aa2612018-01-12
71335-0365-2EA - Each71335-0365e5b7ade3-7c1d-49b1-bf13-e0416d97361c12018-02-20
71335-0365-3EA - Each71335-03654aba28fe-4b4c-4608-8671-f915ce18b56212018-02-20
71335-0365-4EA - Each71335-0365bbae698b-ea35-444f-8165-b599f87e009812018-02-20
71335-0365-5EA - Each71335-036547ed5397-c859-4196-85c1-9bfd9a2440e012018-02-20
71335-0365-6EA - Each71335-0365868c2662-1c05-4cf9-b4aa-46f5b1afefcb12018-02-20
71335-0365-7EA - Each71335-0365243be282-f145-4af1-a105-45719a1d828e12018-02-20
71335-0365-8EA - Each71335-03657d150338-98bb-42ba-812b-502422e7b07212018-02-20
71335-0365-9EA - Each71335-0365a267dde9-4523-4caa-8ef7-07935498880212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0365BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [BRYANT RANCH PREPACK]6Legacy NDC, 10 package rows20220129_65bc1e24-0409-45ad-8b57-afc73e215114.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN65bc1e24-0409-45ad-8b57-afc73e2151146
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD65bc1e24-0409-45ad-8b57-afc73e2151146
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY65bc1e24-0409-45ad-8b57-afc73e2151146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0365-07133503650084 TABLET in 1 BOTTLE (71335-0365-0) 84 tablet2021-12-270000-00-00NoNoCurrent
71335-0365-17133503650120 TABLET in 1 BOTTLE (71335-0365-1) 20 tablet2018-03-230000-00-00NoNoCurrent
71335-0365-27133503650230 TABLET in 1 BOTTLE (71335-0365-2) 30 tablet2018-03-190000-00-00NoNoCurrent
71335-0365-37133503650360 TABLET in 1 BOTTLE (71335-0365-3) 60 tablet2018-02-280000-00-00NoNoCurrent
71335-0365-47133503650490 TABLET in 1 BOTTLE (71335-0365-4) 90 tablet2018-04-190000-00-00NoNoCurrent
71335-0365-57133503650550 TABLET in 1 BOTTLE (71335-0365-5) 50 tablet2021-12-270000-00-00NoNoCurrent
71335-0365-6713350365066 TABLET in 1 BOTTLE (71335-0365-6) 6 tablet2019-05-160000-00-00NoNoCurrent
71335-0365-771335036507120 TABLET in 1 BOTTLE (71335-0365-7) 120 tablet2018-02-150000-00-00NoNoCurrent
71335-0365-87133503650840 TABLET in 1 BOTTLE (71335-0365-8) 40 tablet2019-01-140000-00-00NoNoCurrent
71335-0365-97133503650912 TABLET in 1 BOTTLE (71335-0365-9) 12 tablet2020-05-210000-00-00NoNoCurrent