FDA.reportPublic FDA data

Butalbital, Acetaminophen, and Caffeine

Product NDC
68788-9287
11-digit product format
687889287
Labeler code
68788
Product ID
68788-9287_3c4c8d66-efa6-4831-b656-00ecbe867ece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA088616
Marketing category
ANDA
Marketing start
2015-05-08
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]
NDC exclude flag
No
Listing certified through
2019-12-31
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
68788-9287-12020-01-31C16284748780-19d75b9cf-cddc-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-22020-01-31C16284748780-19d75b9cf-cddc-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-32020-01-31C16284748780-19d75b9cf-cddc-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-62020-01-31C16284748780-19d75b9cf-cddc-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-82020-01-31C16284748780-19d75b9cf-cddc-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-92020-01-31C16284748780-19d75b9cf-cddc-f424-e053-dadaa90a57ceButalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9287-1Butalbital, Acetaminophen, and Caffeine100 in 1 BOTTLETABLET1004
68788-9287-2Butalbital, Acetaminophen, and Caffeine20 in 1 BOTTLETABLET204
68788-9287-3Butalbital, Acetaminophen, and Caffeine30 in 1 BOTTLETABLET304
68788-9287-6Butalbital, Acetaminophen, and Caffeine60 in 1 BOTTLETABLET604
68788-9287-8Butalbital, Acetaminophen, and Caffeine120 in 1 BOTTLETABLET1204
68788-9287-9Butalbital, Acetaminophen, and Caffeine90 in 1 BOTTLETABLET904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9287BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]4Legacy NDC, 6 package rows20180403_d134544e-e54c-41fd-8c89-d7f017fb0829.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNd134544e-e54c-41fd-8c89-d7f017fb08294
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDd134544e-e54c-41fd-8c89-d7f017fb08294
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYd134544e-e54c-41fd-8c89-d7f017fb08294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-9287-168788928701100 in 1 BOTTLEHistorical
68788-9287-26878892870220 in 1 BOTTLEHistorical
68788-9287-36878892870330 in 1 BOTTLEHistorical
68788-9287-66878892870660 in 1 BOTTLEHistorical
68788-9287-868788928708120 in 1 BOTTLEHistorical
68788-9287-96878892870990 in 1 BOTTLEHistorical