Package 68134-403-16

Brand: baclofen

Generic: baclofen
NDC Package

Package Facts

Identity

Package NDC 68134-403-16
Digits Only 6813440316
Product NDC 68134-403
Description

473 mL in 1 BOTTLE (68134-403-16)

Marketing

Marketing Status
Marketed Since 2024-09-25
Brand baclofen
Generic baclofen
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "47426f2f-4630-5a83-e063-6294a90a88d1", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0368134403167"], "unii": ["H789N3FKE8"], "rxcui": ["2667941"], "spl_set_id": ["2422746c-afec-ad30-e063-6394a90a0403"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Palmetto Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (68134-403-16)", "package_ndc": "68134-403-16", "marketing_start_date": "20240925"}], "brand_name": "Baclofen", "product_id": "68134-403_47426f2f-4630-5a83-e063-6294a90a88d1", "dosage_form": "SOLUTION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "68134-403", "generic_name": "Baclofen", "labeler_name": "Palmetto Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/5mL"}], "application_number": "NDA208193", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240925", "listing_expiration_date": "20261231"}