FDA.reportPublic FDA data

Leuprolide Acetate

Product NDC
0781-4003
11-digit product format
007814003
Labeler code
0781
Product ID
0781-4003_e75789aa-7d4c-4107-b140-b24686874a36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leuprolide Acetate
Dosage form
KIT
Labeler
Sandoz Inc
Application
ANDA074728
Marketing category
ANDA
Marketing start
1998-08-04
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leuprolide Acetate
Listing expiration
2027-12-31

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
0781-3006-42Leuprolide Acetate2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL1 mg in 0.2mL24
0781-3006-42Leuprolide Acetate1 in 1 CARTONINJECTION, SOLUTION1 mg in 0.2mL24
0781-4003-32Leuprolide Acetate1 in 1 CARTONKIT124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-4003-32EA - Each0781-4003c4afdd50-d7b7-49ee-aa7e-22df90b628cb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302LEUPROLIDE ACETATE KIT [SANDOZ INC]13
LEUPROLIDE ACETATEACTIVE INGREDIENT37JNS02E7VLEUPROLIDE ACETATE KIT [SANDOZ INC]13
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302LEUPROLIDE ACETATE KIT [SANDOZ INC]13
LEUPROLIDEACTIVE MOIETYEFY6W0M8TGLEUPROLIDE ACETATE KIT [SANDOZ INC]13
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLEUPROLIDE ACETATE KIT [SANDOZ INC]13
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLEUPROLIDE ACETATE KIT [SANDOZ INC]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEUPROLIDE ACETATE KIT [SANDOZ INC]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEUPROLIDE ACETATE KIT [SANDOZ INC]13
WATERINACTIVE INGREDIENT059QF0KO0RLEUPROLIDE ACETATE KIT [SANDOZ INC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-4003LEUPROLIDE ACETATE KIT [SANDOZ INC]21Current NDC, Legacy NDC, 3 package rows20241204_8bd72c1e-2751-4498-a346-bc5e3acbba0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN8bd72c1e-2751-4498-a346-bc5e3acbba0b24
545835leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable SolutionPSN8bd72c1e-2751-4498-a346-bc5e3acbba0b24
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD8bd72c1e-2751-4498-a346-bc5e3acbba0b24
545835leuprolide acetate 5 MG/ML Injectable SolutionSCD8bd72c1e-2751-4498-a346-bc5e3acbba0b24
797544isopropyl alcohol 70 % Medicated PadSY8bd72c1e-2751-4498-a346-bc5e3acbba0b24
797544isopropyl alcohol 70 % Topical ClothSY8bd72c1e-2751-4498-a346-bc5e3acbba0b24
797544isopropyl alcohol 70 % Topical SwabSY8bd72c1e-2751-4498-a346-bc5e3acbba0b24
545835leuprolide acetate 1 MG per 0.2 ML Injectable SolutionSY8bd72c1e-2751-4498-a346-bc5e3acbba0b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3006-42007813006422.8 mL in 1 VIAL, MULTI-DOSE2.8 mlHistorical
0781-4003-32007814003321 KIT in 1 CARTON (0781-4003-32) * 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET1 kit1998-08-040000-00-00NoNoCurrent