baclofen

Generic: baclofen

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-429
Product ID 42571-429_0acb9150-3e4c-9f37-e063-6294a90a7fd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217687
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

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 42571429
Hyphenated Format 42571-429

Supplemental Identifiers

RxCUI
197391 197392 430902
UPC
0342571429010 0342571427016 0342571428013
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 ANDA217687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42571-429-01)
  • 500 TABLET in 1 BOTTLE (42571-429-05)
  • 1000 TABLET in 1 BOTTLE (42571-429-13)
source: ndc

Packages (3)

42571-429-01 100 TABLET in 1 BOTTLE (42571-429-01) 42571-429-05 500 TABLET in 1 BOTTLE (42571-429-05) 42571-429-13 1000 TABLET in 1 BOTTLE (42571-429-13)

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": "0acb9150-3e4c-9f37-e063-6294a90a7fd6", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0342571429010", "0342571427016", "0342571428013"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902"], "spl_set_id": ["f0abf768-3b19-452b-b56d-eb70441cfb18"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42571-429-01)", "package_ndc": "42571-429-01", "marketing_start_date": "20240401"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-429-05)", "package_ndc": "42571-429-05", "marketing_start_date": "20240401"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (42571-429-13)", "package_ndc": "42571-429-13", "marketing_start_date": "20240401"}], "brand_name": "Baclofen", "product_id": "42571-429_0acb9150-3e4c-9f37-e063-6294a90a7fd6", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "42571-429", "generic_name": "Baclofen", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA217687", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}