baclofen

Generic: baclofen

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler lannett company, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 5 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-1333
Product ID 0527-1333_153f6bd7-9462-4d92-b738-48e7807c5919
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077241
Listing Expiration 2026-12-31
Marketing Start 2021-09-22

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 05271333
Hyphenated Format 0527-1333

Supplemental Identifiers

RxCUI
197391 197392 430902
UPC
0305271333018
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 ANDA077241 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0527-1333-01)
source: ndc

Packages (1)

0527-1333-01 100 TABLET in 1 BOTTLE, PLASTIC (0527-1333-01)

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": "153f6bd7-9462-4d92-b738-48e7807c5919", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0305271333018"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902"], "spl_set_id": ["f84f3f4c-17e6-43f1-9600-63b0b175837b"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0527-1333-01)", "package_ndc": "0527-1333-01", "marketing_start_date": "20210922"}], "brand_name": "Baclofen", "product_id": "0527-1333_153f6bd7-9462-4d92-b738-48e7807c5919", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "0527-1333", "generic_name": "baclofen", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/1"}], "application_number": "ANDA077241", "marketing_category": "ANDA", "marketing_start_date": "20210922", "listing_expiration_date": "20261231"}