baclofen

Generic: baclofen

Labeler: nexus pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler nexus pharmaceuticals llc
Dosage Form INJECTION
Routes
INTRATHECAL
Active Ingredients

baclofen 2000 ug/mL

Manufacturer
Nexus Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 14789-161
Product ID 14789-161_2ac0f53e-48b5-5d84-e063-6294a90a8ac8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217324
Listing Expiration 2026-12-31
Marketing Start 2023-02-22

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 14789161
Hyphenated Format 14789-161

Supplemental Identifiers

RxCUI
1666613
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

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 baclofen (source: ndc)
Generic Name baclofen (source: ndc)
Application Number ANDA217324 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 2000 ug/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (14789-161-05) / 20 mL in 1 VIAL
source: ndc

Packages (1)

14789-161-05 1 VIAL in 1 CARTON (14789-161-05) / 20 mL in 1 VIAL

Ingredients (1)

baclofen (2000 ug/mL)

Linked Drug Pages (1)

BACLOFEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL"], "spl_id": "2ac0f53e-48b5-5d84-e063-6294a90a8ac8", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["1666613"], "spl_set_id": ["68c9ade0-d783-43e9-8a3f-a16ec1501ec1"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Nexus Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (14789-161-05)  / 20 mL in 1 VIAL", "package_ndc": "14789-161-05", "marketing_start_date": "20230222"}], "brand_name": "BACLOFEN", "product_id": "14789-161_2ac0f53e-48b5-5d84-e063-6294a90a8ac8", "dosage_form": "INJECTION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "14789-161", "generic_name": "Baclofen", "labeler_name": "Nexus Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "2000 ug/mL"}], "application_number": "ANDA217324", "marketing_category": "ANDA", "marketing_start_date": "20230222", "listing_expiration_date": "20261231"}