FDA.reportPublic FDA data

Rosuvastatin

Product NDC
71610-796
11-digit product format
716100796
Labeler code
71610
Product ID
71610-796_130008fb-8f9d-0c94-e063-6294a90aebdb
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
20 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
ROSUVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
Rxcui859751

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
71610-796-15Rosuvastatin15 in 1 BOTTLETABLET, FILM COATED153
71610-796-30Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED303
71610-796-45Rosuvastatin45 in 1 BOTTLETABLET, FILM COATED453
71610-796-53Rosuvastatin60 in 1 BOTTLETABLET, FILM COATED603
71610-796-60Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-796-15EA - Each71610-796e5acd847-a36d-411f-bfe6-e3a2db128e3a12024-05-16
71610-796-30EA - Each71610-79639f20dd8-a48d-4d6b-9a6d-8ec1a88cf9a512024-04-05
71610-796-45EA - Each71610-7961440601f-2af4-4c7c-8f1d-c924e807d74d12024-04-05
71610-796-53EA - Each71610-796e635584e-ca94-4a8d-afad-fbcf0bde404112024-04-05
71610-796-60EA - Each71610-796f75a7111-3086-4600-a103-d04ac42a381212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-796ROSUVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]3Current NDC, 5 package rows20240308_11701a6e-9b34-4939-e063-6294a90a09c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN11701a6e-9b34-4939-e063-6294a90a09c93
859751rosuvastatin calcium 20 MG Oral TabletSCD11701a6e-9b34-4939-e063-6294a90a09c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-796-157161007961515 TABLET, FILM COATED in 1 BOTTLE (71610-796-15) 2024-03-05NoNoHistorical
71610-796-307161007963030 TABLET, FILM COATED in 1 BOTTLE (71610-796-30) 2024-02-14NoNoHistorical
71610-796-457161007964545 TABLET, FILM COATED in 1 BOTTLE (71610-796-45) 2024-02-14NoNoHistorical
71610-796-537161007965360 TABLET, FILM COATED in 1 BOTTLE (71610-796-53) 2024-02-14NoNoHistorical
71610-796-607161007966090 TABLET, FILM COATED in 1 BOTTLE (71610-796-60) 2024-02-14NoNoHistorical