FDA.reportPublic FDA data

Butalbital, Aspirin and Caffeine

Product NDC
52959-370
11-digit product format
529590370
Labeler code
52959
Product ID
52959-370_463f3a60-1b30-4487-be79-2aa3cea75a51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Aspirin and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company
Application
ANDA086162
Marketing category
ANDA
Marketing start
1979-06-05
Marketing end
0000-00-00
Substance
BUTALBITAL; ASPIRIN; CAFFEINE
Active strength
50 mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2018-12-31
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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct 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
52959-370-002020-01-31C16284748780-19d75b9d0-2bbd-f424-e053-dadaa90a57ceButalbital, Aspirin and Caffeine Tablets, USP
52959-370-022020-01-31C16284748780-19d75b9d0-2bbd-f424-e053-dadaa90a57ceButalbital, Aspirin and Caffeine Tablets, USP
52959-370-122020-01-31C16284748780-19d75b9d0-2bbd-f424-e053-dadaa90a57ceButalbital, Aspirin and Caffeine Tablets, USP
52959-370-202020-01-31C16284748780-19d75b9d0-2bbd-f424-e053-dadaa90a57ceButalbital, Aspirin and Caffeine Tablets, USP
52959-370-252020-01-31C16284748780-19d75b9d0-2bbd-f424-e053-dadaa90a57ceButalbital, Aspirin and Caffeine Tablets, USP
52959-370-302020-01-31C16284748780-19d75b9d0-2bbd-f424-e053-dadaa90a57ceButalbital, Aspirin and Caffeine Tablets, USP
52959-370-502020-01-31C16284748780-19d75b9d0-2bbd-f424-e053-dadaa90a57ceButalbital, Aspirin and Caffeine Tablets, USP
52959-370-602020-01-31C16284748780-19d75b9d0-2bbd-f424-e053-dadaa90a57ceButalbital, Aspirin and Caffeine Tablets, USP
52959-370-902020-01-31C16284748780-19d75b9d0-2bbd-f424-e053-dadaa90a57ceButalbital, Aspirin and Caffeine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-370-00Butalbital, Aspirin and Caffeine100 in 1 BOTTLE, PLASTICTABLET1002
52959-370-02Butalbital, Aspirin and Caffeine120 in 1 BOTTLE, PLASTICTABLET1202
52959-370-12Butalbital, Aspirin and Caffeine12 in 1 BOTTLE, PLASTICTABLET122
52959-370-20Butalbital, Aspirin and Caffeine20 in 1 BOTTLE, PLASTICTABLET202
52959-370-25Butalbital, Aspirin and Caffeine25 in 1 BOTTLE, PLASTICTABLET252
52959-370-30Butalbital, Aspirin and Caffeine30 in 1 BOTTLE, PLASTICTABLET302
52959-370-50Butalbital, Aspirin and Caffeine50 in 1 BOTTLE, PLASTICTABLET502
52959-370-60Butalbital, Aspirin and Caffeine60 in 1 BOTTLE, PLASTICTABLET602
52959-370-90Butalbital, Aspirin and Caffeine90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-370-00EA - Each52959-370e28fdf1c-402a-430e-929d-5326031efcbe12012-07-24
52959-370-02EA - Each52959-3701757e1b1-cf34-4742-bd1b-1fb82425680912012-07-24
52959-370-12EA - Each52959-370038be212-1163-4454-a228-a2603096c22412012-07-24
52959-370-20EA - Each52959-3709143fa90-447e-47fc-8ae5-357ea4059eb212012-07-24
52959-370-25EA - Each52959-370f613c175-7950-4935-8d7f-cd213f5ea95412012-07-24
52959-370-30EA - Each52959-370085aa931-5c89-49f5-8335-3cae05b10baa12012-07-24
52959-370-50EA - Each52959-37019d20ef8-7393-43cc-b5f2-c2896be678a212012-07-24
52959-370-60EA - Each52959-370ea68d5a2-4578-4fd9-80b7-5acd66aae12012012-07-24
52959-370-90EA - Each52959-370ec630f81-f227-4feb-8bc6-999a212fd72712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
ASPIRINACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EABUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-370BUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2Legacy NDC, 9 package rows20120104_2ef4b16c-f553-4a79-b5ee-7893aeb0eae3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-370-0052959037000100 in 1 BOTTLE, PLASTICHistorical
52959-370-0252959037002120 in 1 BOTTLE, PLASTICHistorical
52959-370-125295903701212 in 1 BOTTLE, PLASTICHistorical
52959-370-205295903702020 in 1 BOTTLE, PLASTICHistorical
52959-370-255295903702525 in 1 BOTTLE, PLASTICHistorical
52959-370-305295903703030 in 1 BOTTLE, PLASTICHistorical
52959-370-505295903705050 in 1 BOTTLE, PLASTICHistorical
52959-370-605295903706060 in 1 BOTTLE, PLASTICHistorical
52959-370-905295903709090 in 1 BOTTLE, PLASTICHistorical