baclofen

Generic: baclofen

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

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler xlcare pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
XLCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72865-297
Product ID 72865-297_2d6876fe-19e5-fd4f-e063-6294a90a7960
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212378
Listing Expiration 2026-12-31
Marketing Start 2025-02-05

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 72865297
Hyphenated Format 72865-297

Supplemental Identifiers

RxCUI
197391 197392 430902
UPC
0372865297018 0372865298015
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 ANDA212378 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72865-297-01)
  • 500 TABLET in 1 BOTTLE (72865-297-05)
  • 1000 TABLET in 1 BOTTLE (72865-297-10)
source: ndc

Packages (3)

72865-297-01 100 TABLET in 1 BOTTLE (72865-297-01) 72865-297-05 500 TABLET in 1 BOTTLE (72865-297-05) 72865-297-10 1000 TABLET in 1 BOTTLE (72865-297-10)

Ingredients (1)

baclofen (10 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": "2d6876fe-19e5-fd4f-e063-6294a90a7960", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0372865297018", "0372865298015"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902"], "spl_set_id": ["2b4908fb-47b5-4675-be9e-ca1ad48a7252"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["XLCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72865-297-01)", "package_ndc": "72865-297-01", "marketing_start_date": "20250205"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72865-297-05)", "package_ndc": "72865-297-05", "marketing_start_date": "20250205"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (72865-297-10)", "package_ndc": "72865-297-10", "marketing_start_date": "20250205"}], "brand_name": "BACLOFEN", "product_id": "72865-297_2d6876fe-19e5-fd4f-e063-6294a90a7960", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "72865-297", "generic_name": "BACLOFEN", "labeler_name": "XLCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA212378", "marketing_category": "ANDA", "marketing_start_date": "20250205", "listing_expiration_date": "20261231"}