butalbital, acetaminophen, and caffeine

Generic: butalbital, acetaminophen, and caffeine

Labeler: avkare
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 avkare
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, butalbital 50 mg/1, caffeine 40 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-181
Product ID 42291-181_43545fa6-9313-8af9-e063-6294a90af617
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040885
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2014-11-24

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 42291181
Hyphenated Format 42291-181

Supplemental Identifiers

RxCUI
889520
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 ANDA040885 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 50 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42291-181-01)
source: ndc

Packages (1)

42291-181-01 100 CAPSULE in 1 BOTTLE (42291-181-01)

Ingredients (3)

acetaminophen (300 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": "43545fa6-9313-8af9-e063-6294a90af617", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["889520"], "spl_set_id": ["f5bbad36-6a0e-3518-3f12-138ae9f63980"], "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": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42291-181-01)", "package_ndc": "42291-181-01", "marketing_start_date": "20141124"}], "brand_name": "Butalbital, Acetaminophen, and Caffeine", "product_id": "42291-181_43545fa6-9313-8af9-e063-6294a90af617", "dosage_form": "CAPSULE", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "42291-181", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, and Caffeine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen, and Caffeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}], "application_number": "ANDA040885", "marketing_category": "ANDA", "marketing_start_date": "20141124", "listing_expiration_date": "20261231"}