baclofen

Generic: baclofen

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-219
Product ID 82804-219_0243dd97-1d40-48f7-8853-76e046c605f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209102
Listing Expiration 2026-12-31
Marketing Start 2018-04-01

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 82804219
Hyphenated Format 82804-219

Supplemental Identifiers

RxCUI
430902
UPC
0382804219902
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 ANDA209102 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (82804-219-90)
source: ndc

Packages (1)

82804-219-90 90 TABLET in 1 BOTTLE (82804-219-90)

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": "0243dd97-1d40-48f7-8853-76e046c605f2", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0382804219902"], "unii": ["H789N3FKE8"], "rxcui": ["430902"], "spl_set_id": ["0243dd97-1d40-48f7-8853-76e046c605f2"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-219-90)", "package_ndc": "82804-219-90", "marketing_start_date": "20250424"}], "brand_name": "BACLOFEN", "product_id": "82804-219_0243dd97-1d40-48f7-8853-76e046c605f2", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "82804-219", "generic_name": "BACLOFEN", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/1"}], "application_number": "ANDA209102", "marketing_category": "ANDA", "marketing_start_date": "20180401", "listing_expiration_date": "20261231"}