FDA.reportPublic FDA data

Lupron Depot

Product NDC
0074-3641
11-digit product format
000743641
Labeler code
0074
Product ID
0074-3641_691f9b76-b15b-47c9-8df9-8ebe91999b45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leuprolide acetate
Dosage form
KIT
Labeler
AbbVie Inc.
Application
NDA020011
Marketing category
NDA
Marketing start
1990-10-22
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
Rxcui797544, 1115457, 1115459

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e666f57-491f-16e0-fc75-cc1c9f2fe06fProduct name420250515
43944b95-6cc2-4eca-846a-a5e0ed070616Product name120240501
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5Product name120230829
2ed2d111-4d16-4e2a-9b09-7d196056f6c9Product name120211214
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26Product name120200925
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
ae18ed71-8057-40ec-987f-83624e50b906Product name120150122
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-3641-03Lupron Depot1 in 1 CARTONKIT11478
0074-3641-71Lupron Depot1 in 1 CARTONKIT11478

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-3641-03EA - Each0074-3641d33a7bbb-5a53-4b1b-942c-e6f387a5064012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447
LEUPROLIDE ACETATEACTIVE INGREDIENT37JNS02E7VLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447
LEUPROLIDEACTIVE MOIETYEFY6W0M8TGLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447
GELATININACTIVE INGREDIENT2G86QN327LLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447
MANNITOLINACTIVE INGREDIENT3OWL53L36ALUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447
WATERINACTIVE INGREDIENT059QF0KO0RLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1447

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-3641LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1476Current NDC, Legacy NDC, 2 package rows20241207_00c486b0-bd7b-4898-834d-8c656e5e73cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN00c486b0-bd7b-4898-834d-8c656e5e73cb1478
1115457leuprolide acetate 3.75 MG in 1 ML (1 month) Prefilled SyringePSN00c486b0-bd7b-4898-834d-8c656e5e73cb1478
1115459Lupron Depot 3.75 MG in 1 ML (1 month) Prefilled SyringePSN00c486b0-bd7b-4898-834d-8c656e5e73cb1478
11154591 ML leuprolide acetate 3.75 MG/ML Prefilled Syringe [Lupron]SBD00c486b0-bd7b-4898-834d-8c656e5e73cb1478
11154571 ML leuprolide acetate 3.75 MG/ML Prefilled SyringeSCD00c486b0-bd7b-4898-834d-8c656e5e73cb1478
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD00c486b0-bd7b-4898-834d-8c656e5e73cb1478
11154591 ML Lupron 3.75 MG/ML Prefilled SyringeSY00c486b0-bd7b-4898-834d-8c656e5e73cb1478
797544isopropyl alcohol 70 % Medicated PadSY00c486b0-bd7b-4898-834d-8c656e5e73cb1478
797544isopropyl alcohol 70 % Topical ClothSY00c486b0-bd7b-4898-834d-8c656e5e73cb1478
797544isopropyl alcohol 70 % Topical SwabSY00c486b0-bd7b-4898-834d-8c656e5e73cb1478
1115457leuprolide acetate 3.75 MG per 1 ML (1 month) Prefilled SyringeSY00c486b0-bd7b-4898-834d-8c656e5e73cb1478
1115457leuprolide acetate 3.75 MG per 1 ML Prefilled SyringeSY00c486b0-bd7b-4898-834d-8c656e5e73cb1478
1115459Lupron Depot 3.75 MG per 1 ML (1 month) Prefilled SyringeSY00c486b0-bd7b-4898-834d-8c656e5e73cb1478

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-3641-03000743641031 KIT in 1 CARTON (0074-3641-03) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET1 kit1990-10-220000-00-00NoNoCurrent
0074-3641-71000743641711 KIT in 1 CARTON (0074-3641-71) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET1 kit1990-10-220000-00-00YesNoCurrent