FDA.reportPublic FDA data

FLUVASTATIN SODIUM

Product NDC
0781-8017
11-digit product format
007818017
Labeler code
0781
Product ID
0781-8017_37375ca6-3a81-4d10-9b39-9aee948e51a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluvastatin sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
NDA021192
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-10-16
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
Brand name suffix
ER
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
22ca7ed4-2e69-d74c-9eff-803d6d02a7beProduct name420211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-8017-01FLUVASTATIN SODIUMER100 in 1 BOTTLETABLET, EXTENDED RELEASE1008
0781-8017-31FLUVASTATIN SODIUMER30 in 1 BOTTLETABLET, EXTENDED RELEASE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-8017-01EA - Each0781-80170793e364-8f6e-4501-a5e5-215bb8a787bc12018-06-11
0781-8017-31EA - Each0781-8017dd27b9c9-5389-480d-ba32-a74515c0576812018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8017FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]8Current NDC, Legacy NDC, 2 package rows20241120_5ab4296c-87c2-4c64-b218-d620eef51310.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360507fluvastatin sodium 80 MG 24HR Extended Release Oral TabletPSN5ab4296c-87c2-4c64-b218-d620eef513108
36050724 HR fluvastatin 80 MG Extended Release Oral TabletSCD5ab4296c-87c2-4c64-b218-d620eef513108
360507fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral TabletSY5ab4296c-87c2-4c64-b218-d620eef513108
360507fluvastatin 80 MG 24 HR Extended Release Oral TabletSY5ab4296c-87c2-4c64-b218-d620eef513108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-8017-0100781801701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-01) 2018-05-020000-00-00NoNoCurrent
0781-8017-310078180173130 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-31) 2018-05-020000-00-00NoNoCurrent