FDA.reportPublic FDA data

Fluvastatin Sodium

Product NDC
0093-7446
11-digit product format
000937446
Labeler code
0093
Product ID
0093-7446_82469f87-7755-4dda-a92d-a27856d0fe0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvastatin Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA079011
Marketing category
ANDA
Marketing start
2016-06-02
Substance
FLUVASTATIN SODIUM
Active strength
80 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
Fluvastatin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVASTATIN SODIUM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPYF7O1FV7F
Rxcui360507

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
22ca7ed4-2e69-d74c-9eff-803d6d02a7beProduct name420211021
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7446-01Fluvastatin Sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10010
0093-7446-56Fluvastatin Sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7446-01EA - Each0093-7446940ff00b-ba2b-4666-ae06-11f6ce1fc3e912016-07-19
0093-7446-56EA - Each0093-74466aec1f9a-e839-4a3d-9bd8-d28146ad6d2d12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7446FLUVASTATIN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 2 package rows20240921_cc55110f-1ad6-4f97-840d-62b3a5ac415a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360507fluvastatin sodium 80 MG 24HR Extended Release Oral TabletPSNcc55110f-1ad6-4f97-840d-62b3a5ac415a10
36050724 HR fluvastatin 80 MG Extended Release Oral TabletSCDcc55110f-1ad6-4f97-840d-62b3a5ac415a10
360507fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral TabletSYcc55110f-1ad6-4f97-840d-62b3a5ac415a10
360507fluvastatin 80 MG 24 HR Extended Release Oral TabletSYcc55110f-1ad6-4f97-840d-62b3a5ac415a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7446-0100093744601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-01) 2016-06-020000-00-00NoNoCurrent
0093-7446-560009374465630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-56) 2016-06-020000-00-00NoNoCurrent