FDA.reportPublic FDA data

Leuprolide Acetate

Product NDC
71288-569
11-digit product format
712880569
Labeler code
71288
Product ID
71288-569_fed2b538-4e01-4e4b-9e92-1750554aba61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leuprolide Acetate
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc
Application
ANDA075471
Marketing category
ANDA
Marketing start
2024-05-15
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
71288-350-91Leuprolide Acetate0.5 mL in 1 PACKETSWAB14 mL0.35 mL in 0.5mL2
71288-565-03Leuprolide Acetate2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL5 mg in 1mL2
71288-565-03Leuprolide Acetate1 in 1 CARTONINJECTION, SOLUTION5 mg in 1mL2
71288-569-90Leuprolide Acetate1 in 1 CARTONKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-569-90EA - Each71288-5693a2e90ae-821d-4dea-a5b8-f9ff91a83b3c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-569LEUPROLIDE ACETATE KIT [MEITHEAL PHARMACEUTICALS INC]1Current NDC, 4 package rows20240515_d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842
545835leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable SolutionPSNd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842
545835leuprolide acetate 5 MG/ML Injectable SolutionSCDd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842
797544isopropyl alcohol 70 % Medicated PadSYd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842
797544isopropyl alcohol 70 % Topical ClothSYd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842
797544isopropyl alcohol 70 % Topical SwabSYd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842
545835leuprolide acetate 1 MG per 0.2 ML Injectable SolutionSYd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-350-91712880350910.5 mL in 1 PACKET0.5 mlHistorical
71288-565-03712880565032.8 mL in 1 VIAL, MULTI-DOSE2.8 mlHistorical
71288-569-90712880569901 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91) 1 kit2024-05-15NoNoCurrent