butalbital, acetaminophen, caffeine (80425-0570)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen, caffeine

Generic Name butalbital, acetaminophen, and caffeine

Labeler advanced rx of tennessee, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0570

Product ID 80425-0570_4871bd26-4d42-a212-e063-6294a90a13ca

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209587

DEA Schedule ciii

Listing Expiration 2027-12-31

Marketing Start 2026-01-08

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 804250570

Hyphenated Format 80425-0570

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

30 TABLET in 1 BOTTLE (80425-0570-1)
60 TABLET in 1 BOTTLE (80425-0570-2)
90 TABLET in 1 BOTTLE (80425-0570-3)

source: ndc

Packages (3)

80425-0570-1 30 TABLET in 1 BOTTLE (80425-0570-1) 80425-0570-2 60 TABLET in 1 BOTTLE (80425-0570-2) 80425-0570-3 90 TABLET in 1 BOTTLE (80425-0570-3)

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": "4871bd26-4d42-a212-e063-6294a90a13ca", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["4871c36f-229b-4c12-e063-6394a90a028e"], "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 TABLET in 1 BOTTLE (80425-0570-1)", "package_ndc": "80425-0570-1", "marketing_start_date": "20260108"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0570-2)", "package_ndc": "80425-0570-2", "marketing_start_date": "20260108"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0570-3)", "package_ndc": "80425-0570-3", "marketing_start_date": "20260108"}], "brand_name": "Butalbital, Acetaminophen, Caffeine", "product_id": "80425-0570_4871bd26-4d42-a212-e063-6294a90a13ca", "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": "80425-0570", "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, 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": "20260108", "listing_expiration_date": "20271231"}