Leuprolide Acetate

Product NDC
72664-611
11-digit product format
726640611
Labeler code
72664
Product ID
72664-611_441a43d5-2a8c-2d53-e063-6294a90a385d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leuprolide Acetate
Dosage form
KIT
Labeler
VGYAAN Pharmaceuticals LLC
Application
ANDA213829
Marketing category
ANDA
Marketing start
2020-10-25
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui545835, 797544

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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
ae18ed71-8057-40ec-987f-83624e50b906Product name120150122
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72664-611-28Leuprolide Acetate1 in 1 CARTONKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72664-611-28EA - Each72664-61137201992-7feb-462d-ac8f-45e9369ed8df12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72664-611LEUPROLIDE ACETATE KIT [VGYAAN PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 1 package rows20250110_bec9077a-3f04-4887-856d-dde2de24584d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNbec9077a-3f04-4887-856d-dde2de24584d7
545835leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable SolutionPSNbec9077a-3f04-4887-856d-dde2de24584d7
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDbec9077a-3f04-4887-856d-dde2de24584d7
545835leuprolide acetate 5 MG/ML Injectable SolutionSCDbec9077a-3f04-4887-856d-dde2de24584d7
797544isopropyl alcohol 70 % Medicated PadSYbec9077a-3f04-4887-856d-dde2de24584d7
797544isopropyl alcohol 70 % Topical ClothSYbec9077a-3f04-4887-856d-dde2de24584d7
797544isopropyl alcohol 70 % Topical SwabSYbec9077a-3f04-4887-856d-dde2de24584d7
545835leuprolide acetate 1 MG per 0.2 ML Injectable SolutionSYbec9077a-3f04-4887-856d-dde2de24584d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72664-611-28726640611281 KIT in 1 CARTON (72664-611-28) * 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET1 kit2020-10-250000-00-00NoNoCurrent