FDA.reportPublic FDA data

Lupron Depot

Product NDC
0074-3346
11-digit product format
000743346
Labeler code
0074
Product ID
0074-3346_98a4f293-ee7c-44d0-9a1e-9dc7faf8aaf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leuprolide acetate
Dosage form
KIT
Labeler
AbbVie Inc.
Application
NDA020517
Marketing category
NDA
Marketing start
1995-12-22
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
Rxcui1115257, 1115259, 1115462, 1115464, 1115467, 1115468, 1946521, 1946522

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
0074-3346-03Lupron Depot1 in 1 CARTONKIT11542

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-3346-03EA - Each0074-334605533b67-71be-4aa5-b0e0-4a914acc90d312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEUPROLIDE ACETATEACTIVE INGREDIENT37JNS02E7VLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488
LEUPROLIDEACTIVE MOIETYEFY6W0M8TGLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488
GELATININACTIVE INGREDIENT2G86QN327LLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488
MANNITOLINACTIVE INGREDIENT3OWL53L36ALUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488
POLYLACTIDEINACTIVE INGREDIENT459TN2L5F5LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488
WATERINACTIVE INGREDIENT059QF0KO0RLUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1488

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-3346LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]1540Current NDC, Legacy NDC, 1 package rows20240606_cbc8f94e-7330-4465-05ad-16d64493a5dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115467leuprolide acetate 22.5 MG in 1.5 ML (3 month) Prefilled SyringePSNcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1946521leuprolide acetate 30 MG in 1.5 ML (4 month) Prefilled SyringePSNcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115257leuprolide acetate 45 MG in 1.5 ML (6 month) Prefilled SyringePSNcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115462leuprolide acetate 7.5 MG in 1 ML (1 month) Prefilled SyringePSNcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115468Lupron Depot 22.5 MG in 1.5 ML (3 month) Prefilled SyringePSNcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1946522Lupron Depot 30 MG in 1.5 ML (4 month) Prefilled SyringePSNcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115259Lupron Depot 45 MG in 1.5 ML (6 month) Prefilled SyringePSNcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115464Lupron Depot 7.5 MG in 1 ML (1 month) Prefilled SyringePSNcbc8f94e-7330-4465-05ad-16d64493a5dd1542
11154641 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe [Lupron]SBDcbc8f94e-7330-4465-05ad-16d64493a5dd1542
11154681.5 ML leuprolide acetate 15 MG/ML Prefilled Syringe [Lupron]SBDcbc8f94e-7330-4465-05ad-16d64493a5dd1542
11152591.5 ML leuprolide acetate 30 MG/ML Prefilled Syringe [Lupron]SBDcbc8f94e-7330-4465-05ad-16d64493a5dd1542
19465224-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled Syringe [Lupron]SBDcbc8f94e-7330-4465-05ad-16d64493a5dd1542
11154621 ML leuprolide acetate 7.5 MG/ML Prefilled SyringeSCDcbc8f94e-7330-4465-05ad-16d64493a5dd1542
11154671.5 ML leuprolide acetate 15 MG/ML Prefilled SyringeSCDcbc8f94e-7330-4465-05ad-16d64493a5dd1542
11152571.5 ML leuprolide acetate 30 MG/ML Prefilled SyringeSCDcbc8f94e-7330-4465-05ad-16d64493a5dd1542
19465214-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled SyringeSCDcbc8f94e-7330-4465-05ad-16d64493a5dd1542
11154641 ML Lupron 7.5 MG/ML Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
19465211.5 ML leuprolide acetate 20 MG/ML (4 month) Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
11154681.5 ML Lupron 15 MG/ML Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
11152591.5 ML Lupron 30 MG/ML Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
19465221.5 ML Lupron Depot 20 MG/ML (4 month) Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115467leuprolide acetate 15 MG/ML 1.5 ML (3 month) Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115467leuprolide acetate 15 MG/ML 1.5 ML Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1946521leuprolide acetate 30 MG per 1.5 ML (4 month) Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115257leuprolide acetate 45 MG per 1.5 ML (6 month) Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115462leuprolide acetate 7.5 MG per 1 ML (1 month) Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115468Lupron Depot 22.5 MG per 1.5 ML (3 month) Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115259Lupron Depot 45 MG per 1.5 ML (6 month) Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542
1115464Lupron Depot 7.5 MG per 1 ML (1 month) Prefilled SyringeSYcbc8f94e-7330-4465-05ad-16d64493a5dd1542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-3346-03000743346031 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET1 kit1995-12-230000-00-00NoNoCurrent