FDA.reportPublic FDA data

leuprolide acetate

Product NDC
47335-936
11-digit product format
473350936
Labeler code
47335
Product ID
47335-936_ebfec8b9-a556-4304-af58-2c305db723af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leuprolide acetate
Dosage form
KIT
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078885
Marketing category
ANDA
Marketing start
2014-12-15
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
47335-936-40leuprolide acetate1 in 1 CARTONKIT118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-936-40EA - Each47335-936fb0f9275-a937-4217-b021-f79d0e33c62e12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302LEUPROLIDE ACETATE KIT [SUN PHARMA GLOBAL FZE]5
LEUPROLIDE ACETATEACTIVE INGREDIENT37JNS02E7VLEUPROLIDE ACETATE KIT [SUN PHARMA GLOBAL FZE]5
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302LEUPROLIDE ACETATE KIT [SUN PHARMA GLOBAL FZE]5
LEUPROLIDEACTIVE MOIETYEFY6W0M8TGLEUPROLIDE ACETATE KIT [SUN PHARMA GLOBAL FZE]5
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLEUPROLIDE ACETATE KIT [SUN PHARMA GLOBAL FZE]5
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLEUPROLIDE ACETATE KIT [SUN PHARMA GLOBAL FZE]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEUPROLIDE ACETATE KIT [SUN PHARMA GLOBAL FZE]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEUPROLIDE ACETATE KIT [SUN PHARMA GLOBAL FZE]5
WATERINACTIVE INGREDIENT059QF0KO0RLEUPROLIDE ACETATE KIT [SUN PHARMA GLOBAL FZE]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-936LEUPROLIDE ACETATE KIT [SUN PHARMACEUTICAL INDUSTRIES, INC.]15Current NDC, Legacy NDC, 1 package rows20241127_a3b01473-30c7-4945-bd60-2484221aaaad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNa3b01473-30c7-4945-bd60-2484221aaaad18
545835leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable SolutionPSNa3b01473-30c7-4945-bd60-2484221aaaad18
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDa3b01473-30c7-4945-bd60-2484221aaaad18
545835leuprolide acetate 5 MG/ML Injectable SolutionSCDa3b01473-30c7-4945-bd60-2484221aaaad18
797544isopropyl alcohol 70 % Medicated PadSYa3b01473-30c7-4945-bd60-2484221aaaad18
797544isopropyl alcohol 70 % Topical ClothSYa3b01473-30c7-4945-bd60-2484221aaaad18
797544isopropyl alcohol 70 % Topical SwabSYa3b01473-30c7-4945-bd60-2484221aaaad18
545835leuprolide acetate 1 MG per 0.2 ML Injectable SolutionSYa3b01473-30c7-4945-bd60-2484221aaaad18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-936-40473350936401 KIT in 1 CARTON (47335-936-40) * 1 VIAL, MULTI-DOSE in 1 CARTON / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET1 kit2014-12-150000-00-00NoNoCurrent