FDA.reportPublic FDA data

Leuprolide Acetate

Product NDC
72603-344
11-digit product format
726030344
Labeler code
72603
Product ID
72603-344_384e8664-07e6-3817-e063-6294a90a8385
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leuprolide Acetate
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
NorthStar RxLLC
Application
ANDA213829
Marketing category
ANDA
Marketing start
2024-03-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
2ed2d111-4d16-4e2a-9b09-7d196056f6c9Product name120211214
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26Product name120200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
ae18ed71-8057-40ec-987f-83624e50b906Product name120150122
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-201-01Leuprolide Acetate2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL5 mg in 1mL7
72603-201-01Leuprolide Acetate1 in 1 CARTONINJECTION, SOLUTION5 mg in 1mL7
72603-344-01Leuprolide Acetate1 in 1 CARTONKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-344-01EA - Each72603-344a56b6b42-ae23-492d-9e61-9e256ee26e9812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-344LEUPROLIDE ACETATE KIT [NORTHSTAR RXLLC]5Current NDC, 3 package rows20240622_0cf31b40-816b-d055-e063-6294a90af5d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN0cf31b40-816b-d055-e063-6294a90af5d07
545835leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable SolutionPSN0cf31b40-816b-d055-e063-6294a90af5d07
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD0cf31b40-816b-d055-e063-6294a90af5d07
545835leuprolide acetate 5 MG/ML Injectable SolutionSCD0cf31b40-816b-d055-e063-6294a90af5d07
797544isopropyl alcohol 70 % Medicated PadSY0cf31b40-816b-d055-e063-6294a90af5d07
797544isopropyl alcohol 70 % Topical ClothSY0cf31b40-816b-d055-e063-6294a90af5d07
797544isopropyl alcohol 70 % Topical SwabSY0cf31b40-816b-d055-e063-6294a90af5d07
545835leuprolide acetate 1 MG per 0.2 ML Injectable SolutionSY0cf31b40-816b-d055-e063-6294a90af5d07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-201-01726030201012.8 mL in 1 VIAL, MULTI-DOSE2.8 mlHistorical
72603-344-01726030344011 KIT in 1 CARTON (72603-344-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (72603-201-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 28 PACKET in 1 CARTON / 1 mL in 1 PACKET1 kit2024-03-01NoNoHistorical