butalbital, acetaminophen and caffeine (43547-686)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen and caffeine

Generic Name butalbital, acetaminophen and caffeine

Labeler solco healthcare us, llc

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

SOLCO HEALTHCARE US, LLC

Identifiers & Regulatory

Product NDC 43547-686

Product ID 43547-686_f0520093-dfda-4a04-85c4-9ef3c23a8b60

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214087

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2023-12-05

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 43547686

Hyphenated Format 43547-686

Supplemental Identifiers

RxCUI

889520

UNII

362O9ITL9D KHS0AZ4JVK 3G6A5W338E

NUI

N0000175693 M0002177 N0000175739 N0000175729 N0000175790 M0023046

Packaging Origin

Original Packager

true

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

100 CAPSULE in 1 BOTTLE (43547-686-10)

source: ndc

Packages (1)

43547-686-10 100 CAPSULE in 1 BOTTLE (43547-686-10)

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": "f0520093-dfda-4a04-85c4-9ef3c23a8b60", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["889520"], "spl_set_id": ["5c9c3407-212a-4ae9-a574-2b0c53f3c5eb"], "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": ["SOLCO HEALTHCARE US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (43547-686-10)", "package_ndc": "43547-686-10", "marketing_start_date": "20231205"}], "brand_name": "BUTALBITAL, ACETAMINOPHEN AND CAFFEINE", "product_id": "43547-686_f0520093-dfda-4a04-85c4-9ef3c23a8b60", "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": "43547-686", "dea_schedule": "CIII", "generic_name": "butalbital, acetaminophen and caffeine", "labeler_name": "SOLCO HEALTHCARE US, 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": "20231205", "listing_expiration_date": "20261231"}