FDA.reportPublic FDA data

FLEQSUVY

Product NDC
52652-6001
11-digit product format
526526001
Labeler code
52652
Product ID
52652-6001_461e773b-ccc2-532d-e063-6294a90abad9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA215602
Marketing category
NDA
Marketing start
2022-02-07
Substance
BACLOFEN
Active strength
5 mg/mL
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLEQSUVY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui2593376, 2593382

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52652-6001-1FLEQSUVY1 in 1 CARTONSUSPENSION14
52652-6001-1FLEQSUVY120 mL in 1 BOTTLESUSPENSION1204
52652-6001-2FLEQSUVY300 mL in 1 BOTTLESUSPENSION3004
52652-6001-2FLEQSUVY1 in 1 CARTONSUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52652-6001-1ML - Milliliter52652-60011bb80b10-39d2-4cc5-b5d1-db73c371ca4112022-03-09
52652-6001-2ML - Milliliter52652-60018deb82f0-1cfa-4399-879b-c7de55e5fac412022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52652-6001FLEQSUVY (BACLOFEN) SUSPENSION [AZURITY PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20240517_9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2593376baclofen 5 MG/mL Oral SuspensionPSN9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa4
2593382Fleqsuvy 5 MG/mL Oral SuspensionPSN9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa4
2593382baclofen 5 MG/ML Oral Suspension [Fleqsuvy]SBD9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa4
2593376baclofen 5 MG/ML Oral SuspensionSCD9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa4
2593376baclofen 25 MG per 5 ML Oral SuspensionSY9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa4
2593382Fleqsuvy 25 MG/ 5 ML Oral SuspensionSY9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa4
2593382Fleqsuvy 5 MG/ML Oral SuspensionSY9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52652-6001-1526526001011 BOTTLE in 1 CARTON (52652-6001-1) / 120 mL in 1 BOTTLE1 bottle2022-02-070000-00-00NoNoCurrent
52652-6001-2526526001021 BOTTLE in 1 CARTON (52652-6001-2) / 300 mL in 1 BOTTLE1 bottle2022-02-070000-00-00NoNoCurrent