butalbital, acetaminophen and caffeine (60760-865)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen and caffeine

Generic Name butalbital, acetaminophen and caffeine

Labeler st. mary's medical park pharmacy

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-865

Product ID 60760-865_36229f4e-5921-2fcd-e063-6294a90af60d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040864

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2022-06-29

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 60760865

Hyphenated Format 60760-865

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 and caffeine (source: ndc)

Generic Name butalbital, acetaminophen and caffeine (source: ndc)

Application Number ANDA040864 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
50 mg/1
40 mg/1

source: ndc

Packaging

12 TABLET in 1 BOTTLE, PLASTIC (60760-865-12)

source: ndc

Packages (1)

60760-865-12 12 TABLET in 1 BOTTLE, PLASTIC (60760-865-12)

Ingredients (3)

acetaminophen (325 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": "36229f4e-5921-2fcd-e063-6294a90af60d", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["36229f70-aa73-b112-e063-6394a90a5b49"], "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": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE, PLASTIC (60760-865-12)", "package_ndc": "60760-865-12", "marketing_start_date": "20250519"}], "brand_name": "Butalbital, Acetaminophen and Caffeine", "product_id": "60760-865_36229f4e-5921-2fcd-e063-6294a90af60d", "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": "60760-865", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen and Caffeine", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen and Caffeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}], "application_number": "ANDA040864", "marketing_category": "ANDA", "marketing_start_date": "20220629", "listing_expiration_date": "20261231"}