FDA.reportPublic FDA data

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product NDC
61919-022
11-digit product format
619190022
Labeler code
61919
Product ID
61919-022_a6b845c8-1065-4f9e-e053-2995a90aa6bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA089175
Marketing category
ANDA
Marketing start
2014-01-01
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
2021-12-31
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
61919-022-302025-01-30C16284748780-19d75b9d0-4e64-f424-e053-dadaa90a57ceBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
61919-022-602025-01-30C16284748780-19d75b9d0-4e64-f424-e053-dadaa90a57ceBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
61919-022-902025-01-30C16284748780-19d75b9d0-4e64-f424-e053-dadaa90a57ceBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
61919-022-302020-06-02C16284748780-19d75b9d0-4e64-f424-e053-dadaa90a57ceBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
61919-022-602020-06-02C16284748780-19d75b9d0-4e64-f424-e053-dadaa90a57ceBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
61919-022-902020-06-02C16284748780-19d75b9d0-4e64-f424-e053-dadaa90a57ceBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
61919-022-302020-01-31C16284748780-19d75b9d0-4e64-f424-e053-dadaa90a57ceBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
61919-022-602020-01-31C16284748780-19d75b9d0-4e64-f424-e053-dadaa90a57ceBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
61919-022-902020-01-31C16284748780-19d75b9d0-4e64-f424-e053-dadaa90a57ceBUTALBITAL, ACETAMINOPHEN AND CAFFEINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-022-30BUTALBITAL, ACETAMINOPHEN AND CAFFEINE30 in 1 BOTTLETABLET308
61919-022-60BUTALBITAL, ACETAMINOPHEN AND CAFFEINE60 in 1 BOTTLETABLET608
61919-022-90BUTALBITAL, ACETAMINOPHEN AND CAFFEINE90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-022-30EA - Each61919-0225480d4b9-cb68-4be9-876a-a29b3e776b7012015-10-02
61919-022-60EA - Each61919-0222af9c43d-8420-4135-9681-6ae9ddc0ff0c12015-10-02
61919-022-90EA - Each61919-022150d6e57-7254-4416-87a8-9df3068d030812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-022BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]8Legacy NDC, 3 package rows20230331_c0a97823-63d5-43fa-862f-2acce3185681.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNc0a97823-63d5-43fa-862f-2acce31856818
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDc0a97823-63d5-43fa-862f-2acce31856818
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYc0a97823-63d5-43fa-862f-2acce31856818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-022-306191900223030 TABLET in 1 BOTTLE (61919-022-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-022-606191900226060 TABLET in 1 BOTTLE (61919-022-60) 60 tablet2014-01-010000-00-00NoNoCurrent
61919-022-906191900229090 TABLET in 1 BOTTLE (61919-022-90) 90 tablet2014-01-010000-00-00NoNoCurrent