butalbital and acetaminophen

Generic: butalbital and acetaminophen

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital and acetaminophen
Generic Name butalbital and acetaminophen
Labeler burel pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, butalbital 50 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-455
Product ID 35573-455_f989ac8c-abbb-4bd1-8680-f7177b06f60e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214088
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

Pharmacologic Class

Established (EPC)
barbiturate [epc]
Chemical Structure
barbiturates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573455
Hyphenated Format 35573-455

Supplemental Identifiers

RxCUI
197426 1249617
UPC
0335573455026 0335573456023
UNII
KHS0AZ4JVK 362O9ITL9D
NUI
N0000175693 M0002177

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 and acetaminophen (source: ndc)
Generic Name butalbital and acetaminophen (source: ndc)
Application Number ANDA214088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (35573-455-02)
source: ndc

Packages (1)

35573-455-02 100 TABLET in 1 BOTTLE (35573-455-02)

Ingredients (2)

acetaminophen (300 mg/1) butalbital (50 mg/1)

Linked Drug Pages (1)

BUTALBITAL AND ACETAMINOPHEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f989ac8c-abbb-4bd1-8680-f7177b06f60e", "openfda": {"nui": ["N0000175693", "M0002177"], "upc": ["0335573455026", "0335573456023"], "unii": ["KHS0AZ4JVK", "362O9ITL9D"], "rxcui": ["197426", "1249617"], "spl_set_id": ["0a8a6a16-b23f-45d2-b5d4-540264e74d14"], "pharm_class_cs": ["Barbiturates [CS]"], "pharm_class_epc": ["Barbiturate [EPC]"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (35573-455-02)", "package_ndc": "35573-455-02", "marketing_start_date": "20221201"}], "brand_name": "BUTALBITAL AND ACETAMINOPHEN", "product_id": "35573-455_f989ac8c-abbb-4bd1-8680-f7177b06f60e", "dosage_form": "TABLET", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]"], "product_ndc": "35573-455", "dea_schedule": "CIII", "generic_name": "butalbital and acetaminophen", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUTALBITAL AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}], "application_number": "ANDA214088", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}