butalbital, acetaminophen and caffeine

Generic: butalbital, acetaminophen and caffeine

Labeler: aurolife pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen and caffeine
Generic Name butalbital, acetaminophen and caffeine
Labeler aurolife pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-075
Product ID 13107-075_bc2de4b3-7c0d-48db-b6e1-ee41bfad08e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204733
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2017-04-26

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 13107075
Hyphenated Format 13107-075

Supplemental Identifiers

RxCUI
238153
UPC
0313107075308
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 ANDA204733 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 50 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (13107-075-01)
  • 500 CAPSULE in 1 BOTTLE (13107-075-05)
  • 30 CAPSULE in 1 BOTTLE (13107-075-30)
source: ndc

Packages (3)

13107-075-01 100 CAPSULE in 1 BOTTLE (13107-075-01) 13107-075-05 500 CAPSULE in 1 BOTTLE (13107-075-05) 13107-075-30 30 CAPSULE in 1 BOTTLE (13107-075-30)

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": "bc2de4b3-7c0d-48db-b6e1-ee41bfad08e5", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0313107075308"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238153"], "spl_set_id": ["f9fde75d-7def-48fc-a2b0-727f677f6001"], "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": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (13107-075-01)", "package_ndc": "13107-075-01", "marketing_start_date": "20170426"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (13107-075-05)", "package_ndc": "13107-075-05", "marketing_start_date": "20170426"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (13107-075-30)", "package_ndc": "13107-075-30", "marketing_start_date": "20170426"}], "brand_name": "Butalbital, Acetaminophen and Caffeine", "product_id": "13107-075_bc2de4b3-7c0d-48db-b6e1-ee41bfad08e5", "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": "13107-075", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen and Caffeine", "labeler_name": "Aurolife Pharma, LLC", "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": "ANDA204733", "marketing_category": "ANDA", "marketing_start_date": "20170426", "listing_expiration_date": "20261231"}