butalbital, acetaminophen, and caffeine

Generic: butalbital, acetaminophen, and caffeine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen, and caffeine
Generic Name butalbital, acetaminophen, and caffeine
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, butalbital 50 mg/1, caffeine 40 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6938
Product ID 0904-6938_15290f02-ebc4-485b-a424-df5b107a545f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200243
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2012-09-13

Pharmacologic Class

Established (EPC)
barbiturate [epc] central nervous system stimulant [epc] methylxanthine [epc]
Chemical Structure
barbiturates [cs] xanthines [cs]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046938
Hyphenated Format 0904-6938

Supplemental Identifiers

RxCUI
238154
UNII
362O9ITL9D KHS0AZ4JVK 3G6A5W338E
NUI
N0000175693 M0002177 N0000175739 N0000175729 N0000175790 M0023046

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name butalbital, acetaminophen, and caffeine (source: ndc)
Generic Name butalbital, acetaminophen, and caffeine (source: ndc)
Application Number ANDA200243 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 50 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-6938-06) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6938-06 50 BLISTER PACK in 1 CARTON (0904-6938-06) / 1 TABLET in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) butalbital (50 mg/1) caffeine (40 mg/1)

Linked Drug Pages (1)

Butalbital, Acetaminophen, and Caffeine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "15290f02-ebc4-485b-a424-df5b107a545f", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["0ca49c3c-f2cb-40e3-a7d5-5f48eca59016"], "pharm_class_cs": ["Barbiturates [CS]", "Xanthines [CS]"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Barbiturate [EPC]", "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-6938-06)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6938-06", "marketing_start_date": "20120913"}], "brand_name": "Butalbital, Acetaminophen, and Caffeine", "product_id": "0904-6938_15290f02-ebc4-485b-a424-df5b107a545f", "dosage_form": "TABLET", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "0904-6938", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, and Caffeine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen, and Caffeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}], "application_number": "ANDA200243", "marketing_category": "ANDA", "marketing_start_date": "20120913", "listing_expiration_date": "20261231"}