FDA.reportPublic FDA data

Rosuvastatin

Product NDC
71610-798
11-digit product format
716100798
Labeler code
71610
Product ID
71610-798_20253fa4-28cf-2a97-e063-6294a90af9c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA206381
Marketing category
ANDA
Marketing start
2019-04-24
Substance
ROSUVASTATIN
Active strength
40 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

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
Rxcui859419

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-798-15Rosuvastatin15 in 1 BOTTLETABLET, FILM COATED154
71610-798-16Rosuvastatin6000 in 1 BOTTLETABLET, FILM COATED60004
71610-798-30Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED304
71610-798-45Rosuvastatin45 in 1 BOTTLETABLET, FILM COATED454
71610-798-53Rosuvastatin60 in 1 BOTTLETABLET, FILM COATED604
71610-798-60Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-798-15EA - Each71610-79868fb254a-8f26-4ec5-a713-28cdace4c11812024-04-05
71610-798-16EA - Each71610-7984a1b11ef-1f55-49c9-b344-80fffd6ae3ad12024-08-12
71610-798-30EA - Each71610-7984ed19267-6ae2-425e-a400-888034d897b812024-04-05
71610-798-45EA - Each71610-7988b1de6b9-9161-4da9-a09f-b02c54715c4712024-04-05
71610-798-53EA - Each71610-798ead30f8c-e051-4466-84dc-666045fb17a212024-04-05
71610-798-60EA - Each71610-798ac4f05b5-ae02-4b17-9bbf-46d7cde8a8ef12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-798ROSUVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]4Current NDC, 6 package rows20240822_1185b112-f59d-8762-e063-6394a90a120d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN1185b112-f59d-8762-e063-6394a90a120d4
859419rosuvastatin calcium 40 MG Oral TabletSCD1185b112-f59d-8762-e063-6394a90a120d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-798-157161007981515 TABLET, FILM COATED in 1 BOTTLE (71610-798-15) 2024-02-16NoNoHistorical
71610-798-16716100798166000 TABLET, FILM COATED in 1 BOTTLE (71610-798-16) 2024-06-26NoNoHistorical
71610-798-307161007983030 TABLET, FILM COATED in 1 BOTTLE (71610-798-30) 2024-02-16NoNoHistorical
71610-798-457161007984545 TABLET, FILM COATED in 1 BOTTLE (71610-798-45) 2024-02-16NoNoHistorical
71610-798-537161007985360 TABLET, FILM COATED in 1 BOTTLE (71610-798-53) 2024-02-16NoNoHistorical
71610-798-607161007986090 TABLET, FILM COATED in 1 BOTTLE (71610-798-60) 2024-02-16NoNoHistorical