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 71610-452
Product ID 71610-452_d28f263b-b7d3-47f4-8d3e-bc2fd5594da4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078220
Listing Expiration 2026-12-31
Marketing Start 2020-05-01

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 71610452
Hyphenated Format 71610-452

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 ANDA078220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-452-60)
  • 180 TABLET in 1 BOTTLE, PLASTIC (71610-452-80)
  • 270 TABLET in 1 BOTTLE, PLASTIC (71610-452-92)
source: ndc

Packages (3)

71610-452-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-452-60) 71610-452-80 180 TABLET in 1 BOTTLE, PLASTIC (71610-452-80) 71610-452-92 270 TABLET in 1 BOTTLE, PLASTIC (71610-452-92)

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": "d28f263b-b7d3-47f4-8d3e-bc2fd5594da4", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391"], "spl_set_id": ["d9e5a8b9-1524-41b4-942f-f95015dd17f9"], "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, PLASTIC (71610-452-60)", "package_ndc": "71610-452-60", "marketing_start_date": "20200730"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-452-80)", "package_ndc": "71610-452-80", "marketing_start_date": "20200730"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE, PLASTIC (71610-452-92)", "package_ndc": "71610-452-92", "marketing_start_date": "20200730"}], "brand_name": "Baclofen", "product_id": "71610-452_d28f263b-b7d3-47f4-8d3e-bc2fd5594da4", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "71610-452", "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": "ANDA078220", "marketing_category": "ANDA", "marketing_start_date": "20200501", "listing_expiration_date": "20261231"}