butal/apap/caffeine

Generic: butal/apap/caffeine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butal/apap/caffeine
Generic Name butal/apap/caffeine
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-600
Product ID 72189-600_34a42e66-3892-4594-e063-6294a90a7f6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209587
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2025-01-02

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 72189600
Hyphenated Format 72189-600

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 butal/apap/caffeine (source: ndc)
Generic Name butal/apap/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
  • 12 TABLET in 1 BOTTLE (72189-600-12)
  • 30 TABLET in 1 BOTTLE (72189-600-30)
  • 60 TABLET in 1 BOTTLE (72189-600-60)
source: ndc

Packages (3)

72189-600-12 12 TABLET in 1 BOTTLE (72189-600-12) 72189-600-30 30 TABLET in 1 BOTTLE (72189-600-30) 72189-600-60 60 TABLET in 1 BOTTLE (72189-600-60)

Ingredients (3)

acetaminophen (325 mg/1) butalbital (50 mg/1) caffeine (40 mg/1)

Linked Drug Pages (1)

BUTAL/APAP/CAFFEINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34a42e66-3892-4594-e063-6294a90a7f6b", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["2abb9915-edb2-6218-e063-6394a90ad462"], "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": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE (72189-600-12)", "package_ndc": "72189-600-12", "marketing_start_date": "20250102"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-600-30)", "package_ndc": "72189-600-30", "marketing_start_date": "20250102"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-600-60)", "package_ndc": "72189-600-60", "marketing_start_date": "20250102"}], "brand_name": "BUTAL/APAP/CAFFEINE", "product_id": "72189-600_34a42e66-3892-4594-e063-6294a90a7f6b", "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": "72189-600", "dea_schedule": "CIII", "generic_name": "BUTAL/APAP/CAFFEINE", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUTAL/APAP/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": "20250102", "listing_expiration_date": "20261231"}