FDA.reportPublic FDA data

Lupron Depot-PED

Product NDC
0074-2282
11-digit product format
000742282
Labeler code
0074
Product ID
0074-2282_24e33d5f-c64b-4d45-a5ae-e18a1f696cfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leuprolide acetate
Dosage form
KIT
Labeler
AbbVie Inc.
Application
NDA020263
Marketing category
NDA
Marketing start
1993-04-16
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-PED
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1115447, 1115449, 1115454, 1115456, 1946519, 1946520, 2639668, 2639669, 2639742, 2639743, 2639749, 2639750

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
0074-2282-03Lupron Depot-PED1 in 1 CARTONKIT197

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-2282-03EA - Each0074-22825ad38469-6fee-44f4-9de8-4cde8cc260e112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEUPROLIDE ACETATEACTIVE INGREDIENT37JNS02E7VLUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]36
LEUPROLIDEACTIVE MOIETYEFY6W0M8TGLUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]36
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]36
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]36
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]36
MANNITOLINACTIVE INGREDIENT3OWL53L36ALUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]36
POLYLACTIDEINACTIVE INGREDIENT459TN2L5F5LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]36
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]36
WATERINACTIVE INGREDIENT059QF0KO0RLUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-2282LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]93Current NDC, Legacy NDC, 1 package rows20241109_e99f47d2-da10-3127-ecb3-e5d942ae6e81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115447leuprolide acetate 11.25 MG in 1 ML (pediatric 1 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639749leuprolide acetate 11.25 MG in 1.5 ML (pediatric 3 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1115454leuprolide acetate 15 MG in 1 ML (pediatric 1 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1946519leuprolide acetate 30 MG in 1.5 ML (pediatric 3 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639668leuprolide acetate 45 MG in 1.5 ML (pediatric 6 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639742leuprolide acetate 7.5 MG in 1 ML (pediatric 1 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1115449LUPRON DEPOT-PED 11.25 MG in 1 ML (1 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639750LUPRON DEPOT-PED 11.25 MG in 1.5 ML (3 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1115456LUPRON DEPOT-PED 15 MG in 1 ML (1 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1946520LUPRON DEPOT-PED 30 MG in 1.5 ML (3 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639669LUPRON DEPOT-PED 45 MG in 1.5 ML (6 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639743LUPRON DEPOT-PED 7.5 MG in 1 ML (1 month) Prefilled SyringePSNe99f47d2-da10-3127-ecb3-e5d942ae6e8197
11154491 ML leuprolide acetate 11.25 MG/ML Prefilled Syringe [Lupron]SBDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
11154561 ML leuprolide acetate 15 MG/ML Prefilled Syringe [Lupron]SBDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
19465203-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled Syringe [Lupron]SBDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639743Pediatric 1 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe [Lupron]SBDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639669Pediatric 1.5 ML leuprolide acetate 30 MG/ML Prefilled Syringe [Lupron]SBDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639750Pediatric 1.5 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe [Lupron]SBDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
11154471 ML leuprolide acetate 11.25 MG/ML Prefilled SyringeSCDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
11154541 ML leuprolide acetate 15 MG/ML Prefilled SyringeSCDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
19465193-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled SyringeSCDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639742Pediatric 1 ML leuprolide acetate 7.5 MG/ML Prefilled SyringeSCDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639668Pediatric 1.5 ML leuprolide acetate 30 MG/ML Prefilled SyringeSCDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639749Pediatric 1.5 ML leuprolide acetate 7.5 MG/ML Prefilled SyringeSCDe99f47d2-da10-3127-ecb3-e5d942ae6e8197
11154491 ML Lupron Depot 11.25 MG/ML Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
11154561 ML Lupron Depot 15 MG/ML Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
19465191.5 ML leuprolide acetate 20 MG/ML (3 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
19465201.5 ML Lupron Depot-Ped 20 MG/ML (3 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1115447leuprolide acetate 11.25 MG per 1 ML (pediatric 1 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1115447leuprolide acetate 11.25 MG per 1 ML Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639749leuprolide acetate 11.25 MG per 1.5 ML (pediatric 3 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1115454leuprolide acetate 15 MG per 1 ML (pediatric 1 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1115454leuprolide acetate 15 MG per 1 ML Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1946519leuprolide acetate 30 MG per 1.5 ML (pediatric 3 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639668leuprolide acetate 45 MG per 1.5 ML (pediatric 6 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639742leuprolide acetate 7.5 MG per 1 ML (pediatric 1 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639750Lupron Depot Pediatric 11.25 MG per 1.5 ML (3 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639669Lupron Depot Pediatric 45 MG per 1.5 ML (6 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639743Lupron Depot Pediatric 7.5 MG per 1 ML (1 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1115449Lupron Depot-Ped 11.25 MG per 1 ML (1 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1115456Lupron Depot-Ped 15 MG per 1 ML (1 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
1946520Lupron Depot-Ped 30 MG per 1.5 ML (3 month) Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639669Pediatric Lupron 30 MG/ML Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197
2639743Pediatric Lupron 7.5 MG/ML Prefilled SyringeSYe99f47d2-da10-3127-ecb3-e5d942ae6e8197

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-2282-03000742282031 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET1 kit1993-04-160000-00-00NoNoCurrent