baclofen

Generic: baclofen

Labeler: wilshire pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler wilshire pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

baclofen 5 mg/mL

Manufacturer
Wilshire Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 52536-600
Product ID 52536-600_461e14b2-890c-011c-e063-6294a90a0d4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA215602
Listing Expiration 2026-12-31
Marketing Start 2023-04-01

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 52536600
Hyphenated Format 52536-600

Supplemental Identifiers

RxCUI
2593376
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 NDA215602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (52536-600-11) / 120 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (52536-600-12) / 300 mL in 1 BOTTLE
source: ndc

Packages (2)

52536-600-11 1 BOTTLE in 1 CARTON (52536-600-11) / 120 mL in 1 BOTTLE 52536-600-12 1 BOTTLE in 1 CARTON (52536-600-12) / 300 mL in 1 BOTTLE

Ingredients (1)

baclofen (5 mg/mL)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "461e14b2-890c-011c-e063-6294a90a0d4c", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["2593376"], "spl_set_id": ["4585aafe-0af8-4786-a419-6a7e76671ca2"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Wilshire Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52536-600-11)  / 120 mL in 1 BOTTLE", "package_ndc": "52536-600-11", "marketing_start_date": "20230401"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (52536-600-12)  / 300 mL in 1 BOTTLE", "package_ndc": "52536-600-12", "marketing_start_date": "20230401"}], "brand_name": "Baclofen", "product_id": "52536-600_461e14b2-890c-011c-e063-6294a90a0d4c", "dosage_form": "SUSPENSION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "52536-600", "generic_name": "baclofen", "labeler_name": "Wilshire Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/mL"}], "application_number": "NDA215602", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230401", "listing_expiration_date": "20261231"}