baclofen

Generic: baclofen

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-826
Product ID 60687-826_3b8a78f0-cf6e-1adb-e063-6294a90a55e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211659
Listing Expiration 2026-12-31
Marketing Start 2024-05-26

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 60687826
Hyphenated Format 60687-826

Supplemental Identifiers

RxCUI
197391 197392 430902
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

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 ANDA211659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-826-01) / 1 TABLET in 1 BLISTER PACK (60687-826-11)
source: ndc

Packages (1)

60687-826-01 100 BLISTER PACK in 1 CARTON (60687-826-01) / 1 TABLET in 1 BLISTER PACK (60687-826-11)

Ingredients (1)

baclofen (20 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": "3b8a78f0-cf6e-1adb-e063-6294a90a55e6", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902"], "spl_set_id": ["8b046ee6-28fc-4ab1-b543-414ad0103e5c"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-826-01)  / 1 TABLET in 1 BLISTER PACK (60687-826-11)", "package_ndc": "60687-826-01", "marketing_start_date": "20240526"}], "brand_name": "Baclofen", "product_id": "60687-826_3b8a78f0-cf6e-1adb-e063-6294a90a55e6", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "60687-826", "generic_name": "Baclofen", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA211659", "marketing_category": "ANDA", "marketing_start_date": "20240526", "listing_expiration_date": "20261231"}