butalbital, acetaminophen and caffeine (64950-290)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen and caffeine

Generic Name butalbital, acetaminophen, and caffeine

Labeler genus lifesciences inc.

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/15mL, butalbital 50 mg/15mL, caffeine 40 mg/15mL

Manufacturer

Genus Lifesciences Inc.

Identifiers & Regulatory

Product NDC 64950-290

Product ID 64950-290_791945e1-c3fd-491b-9593-292a6d07bdb6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040387

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2025-07-01

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 64950290

Hyphenated Format 64950-290

Supplemental Identifiers

RxCUI

756245

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 ANDA040387 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/15mL
50 mg/15mL
40 mg/15mL

source: ndc

Packaging

473 mL in 1 BOTTLE (64950-290-16)

source: ndc

Packages (1)

64950-290-16 473 mL in 1 BOTTLE (64950-290-16)

Ingredients (3)

acetaminophen (325 mg/15mL) butalbital (50 mg/15mL) caffeine (40 mg/15mL)

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": "791945e1-c3fd-491b-9593-292a6d07bdb6", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["756245"], "spl_set_id": ["5f603b0d-69e5-4c02-b6b3-b4705e243e9a"], "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": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (64950-290-16)", "package_ndc": "64950-290-16", "marketing_start_date": "20250701"}], "brand_name": "Butalbital, Acetaminophen and Caffeine", "product_id": "64950-290_791945e1-c3fd-491b-9593-292a6d07bdb6", "dosage_form": "SOLUTION", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "64950-290", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, and Caffeine", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen and Caffeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "BUTALBITAL", "strength": "50 mg/15mL"}, {"name": "CAFFEINE", "strength": "40 mg/15mL"}], "application_number": "ANDA040387", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}