baclofen

Generic: baclofen

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

baclofen 5 mg/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-204
Product ID 62559-204_1c95cf7d-6db8-437d-9e33-f8ecb151eca6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217252
Listing Expiration 2026-12-31
Marketing Start 2024-03-18

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 62559204
Hyphenated Format 62559-204

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 ANDA217252 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (62559-204-03) / 300 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (62559-204-12) / 120 mL in 1 BOTTLE
source: ndc

Packages (2)

62559-204-03 1 BOTTLE in 1 CARTON (62559-204-03) / 300 mL in 1 BOTTLE 62559-204-12 1 BOTTLE in 1 CARTON (62559-204-12) / 120 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": "1c95cf7d-6db8-437d-9e33-f8ecb151eca6", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["2593376"], "spl_set_id": ["c73ed3af-8e8a-4a18-90fc-a0f2dcc641d0"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (62559-204-03)  / 300 mL in 1 BOTTLE", "package_ndc": "62559-204-03", "marketing_start_date": "20240319"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62559-204-12)  / 120 mL in 1 BOTTLE", "package_ndc": "62559-204-12", "marketing_start_date": "20240318"}], "brand_name": "Baclofen", "product_id": "62559-204_1c95cf7d-6db8-437d-9e33-f8ecb151eca6", "dosage_form": "SUSPENSION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "62559-204", "generic_name": "Baclofen", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/mL"}], "application_number": "ANDA217252", "marketing_category": "ANDA", "marketing_start_date": "20240318", "listing_expiration_date": "20261231"}