Leuprolide Acetate

Product NDC
63629-8821
11-digit product format
636298821
Labeler code
63629
Product ID
63629-8821_2db23dc7-1f42-434f-a092-088f4109b9a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leuprolide Acetate
Dosage form
KIT
Labeler
Bryant Ranch Prepack
Application
ANDA074728
Marketing category
ANDA
Marketing start
1998-08-04
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-8821-12025-09-16C16284748780-11030e365-65b9-111a-e063-dadaa90a10e219afe51a-3b2d-4286-ad32-992a34bba648
63629-8821-12024-01-30C16284748780-11030e365-65b9-111a-e063-dadaa90a10e219afe51a-3b2d-4286-ad32-992a34bba648

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8821-1EA - Each63629-882154fd2f75-a09f-44ab-8c7a-74e0f486f2ad12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8821LEUPROLIDE ACETATE KIT [BRYANT RANCH PREPACK]101Legacy NDC20220428_19afe51a-3b2d-4286-ad32-992a34bba648.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8821-1636298821011 KIT in 1 CARTON (63629-8821-1) * 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) > 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET1 kit2021-09-100000-00-00NoNoCurrent