butalbital, acetaminophen and caffeine

Generic: butalbital, acetaminophen and caffeine

Labeler: advanced rx of tennessee, llc
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 advanced rx of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0497
Product ID 80425-0497_2e20e0f9-ff3c-5d55-e063-6294a90a13eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214087
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2025-02-14

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 804250497
Hyphenated Format 80425-0497

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 ANDA214087 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 50 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (80425-0497-1)
source: ndc

Packages (1)

80425-0497-1 30 CAPSULE in 1 BOTTLE (80425-0497-1)

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": "2e20e0f9-ff3c-5d55-e063-6294a90a13eb", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["889520"], "spl_set_id": ["2e20e0ee-dd73-6287-e063-6294a90a03b1"], "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": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0497-1)", "package_ndc": "80425-0497-1", "marketing_start_date": "20250214"}], "brand_name": "BUTALBITAL, ACETAMINOPHEN AND CAFFEINE", "product_id": "80425-0497_2e20e0f9-ff3c-5d55-e063-6294a90a13eb", "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": "80425-0497", "dea_schedule": "CIII", "generic_name": "butalbital, acetaminophen and caffeine", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "ANDA214087", "marketing_category": "ANDA", "marketing_start_date": "20250214", "listing_expiration_date": "20261231"}