Butalbital, Aspirin, and Caffeine

Product NDC
33261-922
11-digit product format
332610922
Labeler code
33261
Product ID
33261-922_208b6d91-6e3f-48ac-a86d-767e735dadb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital, aspirin, and caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA017534
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1976-05-04
Marketing end
0000-00-00
Substance
BUTALBITAL; ASPIRIN; CAFFEINE
Active strength
50 mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-922-302020-01-31C16284748780-19d75b9d1-251d-f424-e053-dadaa90a57ceButalbital, Aspirin, and Caffeine Capsules, USP C-III Revised: June 2009 Rx only 1901100609

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-922-30Butalbital, Aspirin, and Caffeine30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-922-30EA - Each33261-9225b7d41f6-0255-4b1e-bcd3-d909260d396412015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-922BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140106_166e131d-9c1a-461f-bf33-e45d4ec36ff2.zip

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
238134aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral CapsuleSCD166e131d-9c1a-461f-bf33-e45d4ec36ff21
238134ASA 325 MG / butalbital 50 MG / Caffeine 40 MG Oral CapsuleSY166e131d-9c1a-461f-bf33-e45d4ec36ff21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-922-303326109223030 in 1 BOTTLE, PLASTICHistorical