EZALLOR SPRINKLE

Product NDC
47335-985
11-digit product format
473350985
Labeler code
47335
Product ID
47335-985_01ae3339-db79-4759-85f9-937689743dc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA208647
Marketing category
NDA
Marketing start
2019-05-04
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-985-60EZALLOR SPRINKLE10 in 1 BLISTER PACKCAPSULE1013
47335-985-64EZALLOR SPRINKLE3 in 1 CARTONCAPSULE313
47335-985-81EZALLOR SPRINKLE90 in 1 BOTTLECAPSULE9013
47335-985-83EZALLOR SPRINKLE30 in 1 BOTTLECAPSULE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-985-83EA - Each47335-98528811a21-0704-4c70-8776-fe495815edb512019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-985EZALLOR SPRINKLE (ROSUVASTATIN) CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 4 package rows20250402_619add8c-3e39-4bb7-8828-450bd82c0404.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-985-604733509856010 in 1 BLISTER PACKHistorical
47335-985-64473350985643 BLISTER PACK in 1 CARTON (47335-985-64) / 10 CAPSULE in 1 BLISTER PACK (47335-985-60) 3 blister pack2019-05-040000-00-00NoNoCurrent
47335-985-814733509858190 CAPSULE in 1 BOTTLE (47335-985-81) 90 capsule2019-05-040000-00-00NoNoCurrent
47335-985-834733509858330 CAPSULE in 1 BOTTLE (47335-985-83) 30 capsule2019-05-040000-00-00NoNoCurrent