butalbital, acetaminophen, caffeine (71205-981)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen, caffeine

Generic Name butalbital, acetaminophen, and caffeine

Labeler proficient rx lp

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-981

Product ID 71205-981_c57a5247-126f-480e-8aab-a992be294dc0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209587

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2019-03-05

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 71205981

Hyphenated Format 71205-981

Supplemental Identifiers

RxCUI

238154

UPC

0371205981303

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

100 TABLET in 1 BOTTLE (71205-981-00)
30 TABLET in 1 BOTTLE (71205-981-30)
500 TABLET in 1 BOTTLE (71205-981-55)
60 TABLET in 1 BOTTLE (71205-981-60)
120 TABLET in 1 BOTTLE (71205-981-72)
90 TABLET in 1 BOTTLE (71205-981-90)

source: ndc

Packages (6)

71205-981-00 100 TABLET in 1 BOTTLE (71205-981-00) 71205-981-30 30 TABLET in 1 BOTTLE (71205-981-30) 71205-981-55 500 TABLET in 1 BOTTLE (71205-981-55) 71205-981-60 60 TABLET in 1 BOTTLE (71205-981-60) 71205-981-72 120 TABLET in 1 BOTTLE (71205-981-72) 71205-981-90 90 TABLET in 1 BOTTLE (71205-981-90)

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": "c57a5247-126f-480e-8aab-a992be294dc0", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0371205981303"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["d860af16-fab4-4263-9e66-a648d5e81dab"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71205-981-00)", "package_ndc": "71205-981-00", "marketing_start_date": "20200507"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-981-30)", "package_ndc": "71205-981-30", "marketing_start_date": "20200507"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (71205-981-55)", "package_ndc": "71205-981-55", "marketing_start_date": "20200507"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-981-60)", "package_ndc": "71205-981-60", "marketing_start_date": "20200507"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71205-981-72)", "package_ndc": "71205-981-72", "marketing_start_date": "20200507"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-981-90)", "package_ndc": "71205-981-90", "marketing_start_date": "20200507"}], "brand_name": "Butalbital, Acetaminophen, Caffeine", "product_id": "71205-981_c57a5247-126f-480e-8aab-a992be294dc0", "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": "71205-981", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, and Caffeine", "labeler_name": "Proficient Rx LP", "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": "20190305", "listing_expiration_date": "20261231"}