FDA.reportPublic FDA data

Fensolvi

Product NDC
62935-163
11-digit product format
629350163
Labeler code
62935
Product ID
62935-163_6ad49800-db23-42bb-8543-1bbb6a9c96f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leuprolide Acetate
Dosage form
INJECTION, SUSPENSION, EXTENDED RELEASE
Route
SUBCUTANEOUS
Labeler
TOLMAR Inc.
Application
NDA213150
Marketing category
NDA
Marketing start
2023-03-06
Substance
LEUPROLIDE ACETATE
Active strength
45 mg/.375mL
Pharmacologic classes
Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUPROLIDE ACETATE45 mg/.375mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii37JNS02E7V
Rxcui752884, 2371773

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e666f57-491f-16e0-fc75-cc1c9f2fe06fProduct name420250515
43944b95-6cc2-4eca-846a-a5e0ed070616Product name120240501
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5Product name120230829
2ed2d111-4d16-4e2a-9b09-7d196056f6c9Product name120211214
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26Product name120200925
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
ae18ed71-8057-40ec-987f-83624e50b906Product name120150122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62935-163-602024-01-30C16284748780-11030e365-5aba-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FENSOLVI ® safely and effectively. See full prescribing information for FENSOLVI. FENSOLVI (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62935-163-60Fensolvi0.375 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.37512
62935-163-60Fensolvi1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62935-163FENSOLVI (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [TOLMAR INC.]11Current NDC, 2 package rows20241025_2c311700-edf4-4f2a-a468-9875489a6cc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2371773Fensolvi 45 MG in 0.375 ML (6 month) Prefilled SyringePSN2c311700-edf4-4f2a-a468-9875489a6cc712
752884leuprolide acetate 45 MG in 0.375 ML (6 month) Prefilled SyringePSN2c311700-edf4-4f2a-a468-9875489a6cc712
23717730.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Fensolvi]SBD2c311700-edf4-4f2a-a468-9875489a6cc712
7528840.375 ML leuprolide acetate 120 MG/ML Prefilled SyringeSCD2c311700-edf4-4f2a-a468-9875489a6cc712
23717730.375 ML Fensolvi 120 MG/ML Prefilled SyringeSY2c311700-edf4-4f2a-a468-9875489a6cc712
2371773Fensolvi Every 6 Months 45 MG per 0.375 ML Prefilled SyringeSY2c311700-edf4-4f2a-a468-9875489a6cc712
752884leuprolide acetate 45 MG per 0.375 ML (6 month) Prefilled SyringeSY2c311700-edf4-4f2a-a468-9875489a6cc712
752884leuprolide acetate 45 MG per 0.375 ML Prefilled SyringeSY2c311700-edf4-4f2a-a468-9875489a6cc712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62935-163-60629350163601 SYRINGE in 1 CARTON (62935-163-60) / .375 mL in 1 SYRINGE1 syringe2023-03-06NoNoCurrent