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 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-446
Product ID 71610-446_edf4b7c6-f843-4177-ba85-410ad266ba81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078401
Listing Expiration 2026-12-31
Marketing Start 2011-01-01

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 71610446
Hyphenated Format 71610-446

Supplemental Identifiers

RxCUI
197392
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 ANDA078401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 45 TABLET in 1 BOTTLE (71610-446-45)
  • 90 TABLET in 1 BOTTLE (71610-446-60)
  • 270 TABLET in 1 BOTTLE (71610-446-92)
source: ndc

Packages (3)

71610-446-45 45 TABLET in 1 BOTTLE (71610-446-45) 71610-446-60 90 TABLET in 1 BOTTLE (71610-446-60) 71610-446-92 270 TABLET in 1 BOTTLE (71610-446-92)

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": "edf4b7c6-f843-4177-ba85-410ad266ba81", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197392"], "spl_set_id": ["9edc00c6-c281-4e81-b176-44b7536f71f2"], "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": "45 TABLET in 1 BOTTLE (71610-446-45)", "package_ndc": "71610-446-45", "marketing_start_date": "20200721"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-446-60)", "package_ndc": "71610-446-60", "marketing_start_date": "20200721"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-446-92)", "package_ndc": "71610-446-92", "marketing_start_date": "20200730"}], "brand_name": "Baclofen", "product_id": "71610-446_edf4b7c6-f843-4177-ba85-410ad266ba81", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "71610-446", "generic_name": "Baclofen", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA078401", "marketing_category": "ANDA", "marketing_start_date": "20110101", "listing_expiration_date": "20261231"}