FDA.reportPublic FDA data

Lupron Depot

Product NDC
0074-3663
11-digit product format
000743663
Labeler code
0074
Product ID
0074-3663_fef36994-8fde-4b22-99a9-aa850c147eee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leuprolide acetate
Dosage form
KIT
Labeler
AbbVie Inc.
Application
NDA020708
Marketing category
NDA
Marketing start
2010-11-08
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1115472, 1115473

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
0074-3663-03Lupron Depot1 in 1 CARTONKIT11517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-3663-03EA - Each0074-36634408cf6c-86ba-4dc6-bc39-baae6e4b9b2a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1450
LEUPROLIDE ACETATEACTIVE INGREDIENT37JNS02E7VLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1450
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1450
LEUPROLIDEACTIVE MOIETYEFY6W0M8TGLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1450
MANNITOLINACTIVE INGREDIENT3OWL53L36ALUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1450

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-3663LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1515Current NDC, Legacy NDC, 1 package rows20241207_60aad237-e1da-4705-cbbb-b3ca79e89ad8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115472leuprolide acetate 11.25 MG in 1.5 ML (3 month) Prefilled SyringePSN60aad237-e1da-4705-cbbb-b3ca79e89ad81517
1115473Lupron Depot 11.25 MG in 1.5 ML (3 month) Prefilled SyringePSN60aad237-e1da-4705-cbbb-b3ca79e89ad81517
11154731.5 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe [Lupron]SBD60aad237-e1da-4705-cbbb-b3ca79e89ad81517
11154721.5 ML leuprolide acetate 7.5 MG/ML Prefilled SyringeSCD60aad237-e1da-4705-cbbb-b3ca79e89ad81517
11154731.5 ML Lupron Depot 7.5 MG/ML Prefilled SyringeSY60aad237-e1da-4705-cbbb-b3ca79e89ad81517
1115472leuprolide acetate 11.25 MG per 1.5 ML (3 month) Prefilled SyringeSY60aad237-e1da-4705-cbbb-b3ca79e89ad81517
1115472leuprolide acetate 11.25 MG per 1.5 ML Prefilled SyringeSY60aad237-e1da-4705-cbbb-b3ca79e89ad81517
1115473Lupron Depot 11.25 MG per 1.5 ML (3 month) Prefilled SyringeSY60aad237-e1da-4705-cbbb-b3ca79e89ad81517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-3663-03000743663031 KIT in 1 CARTON (0074-3663-03) * 1.5 mL in 1 SYRINGE * 1 mL in 1 PACKET1 kit2010-11-080000-00-00NoNoCurrent