fleqsuvy

Generic: baclofen

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fleqsuvy
Generic Name baclofen
Labeler azurity pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

baclofen 5 mg/mL

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 52652-6001
Product ID 52652-6001_461e773b-ccc2-532d-e063-6294a90abad9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215602
Listing Expiration 2026-12-31
Marketing Start 2022-02-07

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 526526001
Hyphenated Format 52652-6001

Supplemental Identifiers

RxCUI
2593376 2593382
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 fleqsuvy (source: ndc)
Generic Name baclofen (source: ndc)
Application Number NDA215602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (52652-6001-1) / 120 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (52652-6001-2) / 300 mL in 1 BOTTLE
source: ndc

Packages (2)

52652-6001-1 1 BOTTLE in 1 CARTON (52652-6001-1) / 120 mL in 1 BOTTLE 52652-6001-2 1 BOTTLE in 1 CARTON (52652-6001-2) / 300 mL in 1 BOTTLE

Ingredients (1)

baclofen (5 mg/mL)

Linked Drug Pages (1)

FLEQSUVY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "461e773b-ccc2-532d-e063-6294a90abad9", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["2593376", "2593382"], "spl_set_id": ["9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52652-6001-1)  / 120 mL in 1 BOTTLE", "package_ndc": "52652-6001-1", "marketing_start_date": "20220207"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (52652-6001-2)  / 300 mL in 1 BOTTLE", "package_ndc": "52652-6001-2", "marketing_start_date": "20220207"}], "brand_name": "FLEQSUVY", "product_id": "52652-6001_461e773b-ccc2-532d-e063-6294a90abad9", "dosage_form": "SUSPENSION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "52652-6001", "generic_name": "baclofen", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLEQSUVY", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/mL"}], "application_number": "NDA215602", "marketing_category": "NDA", "marketing_start_date": "20220207", "listing_expiration_date": "20261231"}