butalbital and acetaminophen

Generic: butalbital and acetaminophen

Labeler: dr. reddy's labratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital and acetaminophen
Generic Name butalbital and acetaminophen
Labeler dr. reddy's labratories inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, butalbital 50 mg/1

Manufacturer
Dr. Reddy's Labratories Inc.

Identifiers & Regulatory

Product NDC 75907-008
Product ID 75907-008_a511d156-e9d4-8158-9833-b4e6653b4bcf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207313
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2024-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75907008
Hyphenated Format 75907-008

Supplemental Identifiers

RxCUI
1995136
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 ANDA207313 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (75907-008-01)
source: ndc

Packages (1)

75907-008-01 100 CAPSULE in 1 BOTTLE (75907-008-01)

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": "a511d156-e9d4-8158-9833-b4e6653b4bcf", "openfda": {"nui": ["N0000175693", "M0002177"], "unii": ["362O9ITL9D", "KHS0AZ4JVK"], "rxcui": ["1995136"], "spl_set_id": ["42d808d6-d8d4-22f5-ac2f-0f0d1d71686a"], "pharm_class_cs": ["Barbiturates [CS]"], "pharm_class_epc": ["Barbiturate [EPC]"], "manufacturer_name": ["Dr. Reddy's Labratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (75907-008-01)", "package_ndc": "75907-008-01", "marketing_start_date": "20240901"}], "brand_name": "butalbital and acetaminophen", "product_id": "75907-008_a511d156-e9d4-8158-9833-b4e6653b4bcf", "dosage_form": "CAPSULE", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]"], "product_ndc": "75907-008", "dea_schedule": "CIII", "generic_name": "butalbital and acetaminophen", "labeler_name": "Dr. Reddy's Labratories Inc.", "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": "ANDA207313", "marketing_category": "ANDA", "marketing_start_date": "20240901", "listing_expiration_date": "20261231"}