baclofen

Generic: baclofen

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRATHECAL
Active Ingredients

baclofen 500 ug/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-678
Product ID 25021-678_9ae563da-240a-468d-bc42-ed4667df2392
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210048
Listing Expiration 2026-12-31
Marketing Start 2021-07-15

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 25021678
Hyphenated Format 25021-678

Supplemental Identifiers

RxCUI
308517 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 ANDA210048 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-678-20) / 20 mL in 1 VIAL
source: ndc

Packages (1)

25021-678-20 1 VIAL in 1 CARTON (25021-678-20) / 20 mL in 1 VIAL

Ingredients (1)

baclofen (500 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": "9ae563da-240a-468d-bc42-ed4667df2392", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["308517", "1666613"], "spl_set_id": ["077aaf3b-1ca3-4599-a51a-6bbe39810ca8"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-678-20)  / 20 mL in 1 VIAL", "package_ndc": "25021-678-20", "marketing_start_date": "20210715"}], "brand_name": "Baclofen", "product_id": "25021-678_9ae563da-240a-468d-bc42-ed4667df2392", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "25021-678", "generic_name": "Baclofen", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "500 ug/mL"}], "application_number": "ANDA210048", "marketing_category": "ANDA", "marketing_start_date": "20210715", "listing_expiration_date": "20261231"}