butalbital and acetaminophen (68047-753)

Drug Facts

Product Profile

Brand Name butalbital and acetaminophen

Generic Name butalbital and acetaminophen

Labeler larken laboratories, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, butalbital 25 mg/1

Manufacturer

Larken Laboratories, Inc.

Identifiers & Regulatory

Product NDC 68047-753

Product ID 68047-753_41348343-4fef-7234-e063-6394a90af41d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203484

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2015-12-04

Pharmacologic Class

Established (EPC)

barbiturate [epc]

Chemical Structure

barbiturates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68047753

Hyphenated Format 68047-753

Supplemental Identifiers

RxCUI

197426 1724446 2279007

UPC

0368047753014 0368047752017 0368047721013

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 ANDA203484 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
25 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (68047-753-01)
30 TABLET in 1 BOTTLE (68047-753-30)

source: ndc

Packages (2)

68047-753-01 100 TABLET in 1 BOTTLE (68047-753-01) 68047-753-30 30 TABLET in 1 BOTTLE (68047-753-30)

Ingredients (2)

acetaminophen (325 mg/1) butalbital (25 mg/1)

Linked Drug Pages (1)

Butalbital And Acetaminophen, ALLZITAL, Butalbital and Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "41348343-4fef-7234-e063-6394a90af41d", "openfda": {"nui": ["N0000175693", "M0002177"], "upc": ["0368047753014", "0368047752017", "0368047721013"], "unii": ["KHS0AZ4JVK", "362O9ITL9D"], "rxcui": ["197426", "1724446", "2279007"], "spl_set_id": ["326c83fc-afed-45ad-9c87-f47968fa1d2a"], "pharm_class_cs": ["Barbiturates [CS]"], "pharm_class_epc": ["Barbiturate [EPC]"], "manufacturer_name": ["Larken Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68047-753-01)", "package_ndc": "68047-753-01", "marketing_start_date": "20220718"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68047-753-30)", "package_ndc": "68047-753-30", "marketing_start_date": "20220718"}], "brand_name": "Butalbital and Acetaminophen", "product_id": "68047-753_41348343-4fef-7234-e063-6394a90af41d", "dosage_form": "TABLET", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]"], "product_ndc": "68047-753", "dea_schedule": "CIII", "generic_name": "butalbital and acetaminophen", "labeler_name": "Larken Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "25 mg/1"}], "application_number": "ANDA203484", "marketing_category": "ANDA", "marketing_start_date": "20151204", "listing_expiration_date": "20261231"}