baclofen

Generic: baclofen

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-105
Product ID 50268-105_2b489a19-55e7-8503-e063-6294a90aa6e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211659
Listing Expiration 2026-12-31
Marketing Start 2021-05-11

Pharmacologic Class

Established (EPC)
gamma-aminobutyric acid-ergic agonist [epc]
Mechanism of Action
gaba a agonists [moa] gaba b agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268105
Hyphenated Format 50268-105

Supplemental Identifiers

RxCUI
430902
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

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 baclofen (source: ndc)
Generic Name baclofen (source: ndc)
Application Number ANDA211659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-105-15) / 1 TABLET in 1 BLISTER PACK (50268-105-11)
source: ndc

Packages (1)

50268-105-15 50 BLISTER PACK in 1 BOX (50268-105-15) / 1 TABLET in 1 BLISTER PACK (50268-105-11)

Ingredients (1)

baclofen (5 mg/1)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b489a19-55e7-8503-e063-6294a90aa6e2", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["430902"], "spl_set_id": ["c21095a9-17b1-555a-e053-2a95a90a51fd"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-105-15)  / 1 TABLET in 1 BLISTER PACK (50268-105-11)", "package_ndc": "50268-105-15", "marketing_start_date": "20210511"}], "brand_name": "Baclofen", "product_id": "50268-105_2b489a19-55e7-8503-e063-6294a90aa6e2", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "50268-105", "generic_name": "Baclofen", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/1"}], "application_number": "ANDA211659", "marketing_category": "ANDA", "marketing_start_date": "20210511", "listing_expiration_date": "20261231"}