baclofen

Generic: baclofen

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-660
Product ID 71610-660_70e07130-7d44-48d3-9ad3-f9ea3477ba2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212378
Listing Expiration 2026-12-31
Marketing Start 2020-10-09

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 71610660
Hyphenated Format 71610-660

Supplemental Identifiers

RxCUI
197391
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 ANDA212378 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-660-60)
  • 180 TABLET in 1 BOTTLE (71610-660-80)
  • 270 TABLET in 1 BOTTLE (71610-660-92)
source: ndc

Packages (3)

71610-660-60 90 TABLET in 1 BOTTLE (71610-660-60) 71610-660-80 180 TABLET in 1 BOTTLE (71610-660-80) 71610-660-92 270 TABLET in 1 BOTTLE (71610-660-92)

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": "70e07130-7d44-48d3-9ad3-f9ea3477ba2e", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391"], "spl_set_id": ["edef7819-875f-4855-8f1f-32407f82e9dc"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-660-60)", "package_ndc": "71610-660-60", "marketing_start_date": "20220901"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-660-80)", "package_ndc": "71610-660-80", "marketing_start_date": "20220901"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-660-92)", "package_ndc": "71610-660-92", "marketing_start_date": "20220901"}], "brand_name": "Baclofen", "product_id": "71610-660_70e07130-7d44-48d3-9ad3-f9ea3477ba2e", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "71610-660", "generic_name": "Baclofen", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "20201009", "listing_expiration_date": "20261231"}