Butalbital, Aspirin, and Caffeine

Product NDC
0591-3219
11-digit product format
005913219
Labeler code
0591
Product ID
0591-3219_7405aa53-b345-4fbf-9c41-8a7a27cc90ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital, aspirin, and caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA017534
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2003-10-06
Marketing end
2023-05-31
Substance
ASPIRIN; BUTALBITAL; CAFFEINE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
0000-00-00
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0591-3219-01EA - Each0591-321980a38469-6f5a-4488-af6c-1ab68b4f5f7412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
butalbitalACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
caffeineACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
aspirinACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
ASPIRINACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
ASPIRINACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
butalbitalACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
caffeineACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]1
talcINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238134butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral CapsulePSN166e131d-9c1a-461f-bf33-e45d4ec36ff21
238134butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral CapsulePSNaa9bfa49-c3b3-419d-a283-5ea0fd6fc3a01
238134butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral CapsulePSNc69954d9-9b30-484f-8e4a-5b1fc7dd197d1
238134aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral CapsuleSCD166e131d-9c1a-461f-bf33-e45d4ec36ff21
238134aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral CapsuleSCDaa9bfa49-c3b3-419d-a283-5ea0fd6fc3a01
238134aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral CapsuleSCDc69954d9-9b30-484f-8e4a-5b1fc7dd197d1
238134ASA 325 MG / butalbital 50 MG / Caffeine 40 MG Oral CapsuleSY166e131d-9c1a-461f-bf33-e45d4ec36ff21
238134ASA 325 MG / butalbital 50 MG / Caffeine 40 MG Oral CapsuleSYaa9bfa49-c3b3-419d-a283-5ea0fd6fc3a01
238134ASA 325 MG / butalbital 50 MG / Caffeine 40 MG Oral CapsuleSYc69954d9-9b30-484f-8e4a-5b1fc7dd197d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3219-0100591321901100 CAPSULE in 1 BOTTLE (0591-3219-01) 100 capsule2003-10-060000-00-00NoNoCurrent