baclofen

Generic: baclofen

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 5 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-169
Product ID 16571-169_ff66a259-5803-47a3-9558-87acf43f43a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214374
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

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 16571169
Hyphenated Format 16571-169

Supplemental Identifiers

RxCUI
197391 197392 430902
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 ANDA214374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-169-01)
source: ndc

Packages (1)

16571-169-01 100 TABLET in 1 BOTTLE (16571-169-01)

Ingredients (1)

baclofen (5 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": "ff66a259-5803-47a3-9558-87acf43f43a7", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902"], "spl_set_id": ["6eb46715-d72b-473f-b984-90024033d4a0"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-169-01)", "package_ndc": "16571-169-01", "marketing_start_date": "20240301"}], "brand_name": "BACLOFEN", "product_id": "16571-169_ff66a259-5803-47a3-9558-87acf43f43a7", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "16571-169", "generic_name": "BACLOFEN", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/1"}], "application_number": "ANDA214374", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}