butalbital and acetaminophen (70752-147)

Drug Facts

Product Profile

Brand Name butalbital and acetaminophen

Generic Name butalbital and acetaminophen

Labeler quagen pharmaceuticals llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, butalbital 50 mg/1

Manufacturer

QUAGEN PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 70752-147

Product ID 70752-147_1d75a5ef-9dbe-4e3b-bc91-ffc68c88b3af

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214305

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2024-05-01

Pharmacologic Class

Established (EPC)

barbiturate [epc]

Chemical Structure

barbiturates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70752147

Hyphenated Format 70752-147

Supplemental Identifiers

RxCUI

1249617

UNII

362O9ITL9D KHS0AZ4JVK

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 ANDA214305 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
50 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (70752-147-10)
500 TABLET in 1 BOTTLE, PLASTIC (70752-147-14)

source: ndc

Packages (2)

70752-147-10 100 TABLET in 1 BOTTLE, PLASTIC (70752-147-10) 70752-147-14 500 TABLET in 1 BOTTLE, PLASTIC (70752-147-14)

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": "1d75a5ef-9dbe-4e3b-bc91-ffc68c88b3af", "openfda": {"nui": ["N0000175693", "M0002177"], "unii": ["362O9ITL9D", "KHS0AZ4JVK"], "rxcui": ["1249617"], "spl_set_id": ["1f0dbe62-6aea-4323-ad25-c2211f919253"], "pharm_class_cs": ["Barbiturates [CS]"], "pharm_class_epc": ["Barbiturate [EPC]"], "manufacturer_name": ["QUAGEN PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (70752-147-10)", "package_ndc": "70752-147-10", "marketing_start_date": "20240501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (70752-147-14)", "package_ndc": "70752-147-14", "marketing_start_date": "20240501"}], "brand_name": "BUTALBITAL and ACETAMINOPHEN", "product_id": "70752-147_1d75a5ef-9dbe-4e3b-bc91-ffc68c88b3af", "dosage_form": "TABLET", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]"], "product_ndc": "70752-147", "dea_schedule": "CIII", "generic_name": "BUTALBITAL and ACETAMINOPHEN", "labeler_name": "QUAGEN 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": "ANDA214305", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}