butalbital, acetaminophen, caffeine

Generic: butalbital, acetaminophen, and caffeine

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen, caffeine
Generic Name butalbital, acetaminophen, and caffeine
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-802
Product ID 76420-802_44818491-48a2-ba4d-e063-6394a90a65f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209587
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-03-05

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 76420802
Hyphenated Format 76420-802

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, caffeine (source: ndc)
Generic Name butalbital, acetaminophen, and caffeine (source: ndc)
Application Number ANDA209587 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 50 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76420-802-01)
  • 500 TABLET in 1 BOTTLE (76420-802-05)
  • 10 TABLET in 1 BOTTLE (76420-802-10)
  • 12 TABLET in 1 BOTTLE (76420-802-12)
  • 20 TABLET in 1 BOTTLE (76420-802-20)
  • 30 TABLET in 1 BOTTLE (76420-802-30)
  • 60 TABLET in 1 BOTTLE (76420-802-60)
  • 90 TABLET in 1 BOTTLE (76420-802-90)
source: ndc

Packages (8)

76420-802-01 100 TABLET in 1 BOTTLE (76420-802-01) 76420-802-05 500 TABLET in 1 BOTTLE (76420-802-05) 76420-802-10 10 TABLET in 1 BOTTLE (76420-802-10) 76420-802-12 12 TABLET in 1 BOTTLE (76420-802-12) 76420-802-20 20 TABLET in 1 BOTTLE (76420-802-20) 76420-802-30 30 TABLET in 1 BOTTLE (76420-802-30) 76420-802-60 60 TABLET in 1 BOTTLE (76420-802-60) 76420-802-90 90 TABLET in 1 BOTTLE (76420-802-90)

Ingredients (3)

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

Linked Drug Pages (1)

Butalbital, Acetaminophen, Caffeine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44818491-48a2-ba4d-e063-6394a90a65f9", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["cce09e09-158f-4927-8a3e-4ec9334f0b7a"], "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": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-802-01)", "package_ndc": "76420-802-01", "marketing_start_date": "20240429"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76420-802-05)", "package_ndc": "76420-802-05", "marketing_start_date": "20240429"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (76420-802-10)", "package_ndc": "76420-802-10", "marketing_start_date": "20240429"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (76420-802-12)", "package_ndc": "76420-802-12", "marketing_start_date": "20240429"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (76420-802-20)", "package_ndc": "76420-802-20", "marketing_start_date": "20240429"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-802-30)", "package_ndc": "76420-802-30", "marketing_start_date": "20240429"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-802-60)", "package_ndc": "76420-802-60", "marketing_start_date": "20240429"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-802-90)", "package_ndc": "76420-802-90", "marketing_start_date": "20240429"}], "brand_name": "Butalbital, Acetaminophen, Caffeine", "product_id": "76420-802_44818491-48a2-ba4d-e063-6394a90a65f9", "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": "76420-802", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, and Caffeine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen, Caffeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}], "application_number": "ANDA209587", "marketing_category": "ANDA", "marketing_start_date": "20190305", "listing_expiration_date": "20261231"}