butalbital and acetaminophen

Generic: butalbital and acetaminophen

Labeler: endo usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital and acetaminophen
Generic Name butalbital and acetaminophen
Labeler endo usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, butalbital 50 mg/1

Manufacturer
Endo USA

Identifiers & Regulatory

Product NDC 0603-2540
Product ID 0603-2540_2d7cd016-87b7-12bf-e063-6294a90ac288
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089987
Listing Expiration 2026-12-31
Marketing Start 1999-06-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06032540
Hyphenated Format 0603-2540

Supplemental Identifiers

RxCUI
197426
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 ANDA089987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0603-2540-21)
source: ndc

Packages (1)

0603-2540-21 100 TABLET in 1 BOTTLE (0603-2540-21)

Ingredients (2)

acetaminophen (325 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": "2d7cd016-87b7-12bf-e063-6294a90ac288", "openfda": {"nui": ["N0000175693", "M0002177"], "unii": ["362O9ITL9D", "KHS0AZ4JVK"], "rxcui": ["197426"], "spl_set_id": ["e619b656-4123-4878-b601-b0edad3c428b"], "pharm_class_cs": ["Barbiturates [CS]"], "pharm_class_epc": ["Barbiturate [EPC]"], "manufacturer_name": ["Endo USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0603-2540-21)", "package_ndc": "0603-2540-21", "marketing_start_date": "19990603"}], "brand_name": "butalbital and acetaminophen", "product_id": "0603-2540_2d7cd016-87b7-12bf-e063-6294a90ac288", "dosage_form": "TABLET", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]"], "product_ndc": "0603-2540", "generic_name": "butalbital and acetaminophen", "labeler_name": "Endo USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "butalbital and acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}], "application_number": "ANDA089987", "marketing_category": "ANDA", "marketing_start_date": "19990603", "listing_expiration_date": "20261231"}