FDA.reportPublic FDA data

Butalbital, Aspirin and Caffeine

Product NDC
0143-1785
11-digit product format
001431785
Labeler code
0143
Product ID
0143-1785_576e3e85-d465-4c0f-9d8a-3a786e2becd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Aspirin and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
West-ward Pharmaceutical Corp
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1785-01EA - Each0143-178566237812-01e7-4407-bc62-cfb56482860612012-07-24
0143-1785-10EA - Each0143-1785fb1ecd62-7bab-44cc-875b-7bea0b08417012012-07-24
0143-1785-30EA - Each0143-1785dbbb0671-2494-4b13-aa7d-9add99f52cc512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
ASPIRINACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EABUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [DISPENSING SOLUTIONS, INC.]2
ASPIRINACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
ASPIRINACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238135butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral TabletPSN657e4c4a-e50c-49f7-99b4-32395ec19bd82
238135aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD657e4c4a-e50c-49f7-99b4-32395ec19bd82
238135ASA 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY657e4c4a-e50c-49f7-99b4-32395ec19bd82
238135butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral TabletPSN4e10129b-41a3-4572-9564-6f8366b627dc1
238135aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD4e10129b-41a3-4572-9564-6f8366b627dc1
238135ASA 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY4e10129b-41a3-4572-9564-6f8366b627dc1