Fluvastatin

Product NDC
0093-7442
11-digit product format
000937442
Labeler code
0093
Product ID
0093-7442_1fb50b66-e9d0-4fd1-928e-b37c4fff4ccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvastatin
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA078407
Marketing category
ANDA
Marketing start
2012-07-05
Substance
FLUVASTATIN SODIUM
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
Fluvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVASTATIN SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPYF7O1FV7F
Rxcui310404, 310405

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
0093-7442-01Fluvastatin100 in 1 BOTTLECAPSULE10012
0093-7442-56Fluvastatin30 in 1 BOTTLECAPSULE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7442-01EA - Each0093-74421a85b40d-4a2d-4cae-92a8-bb359491480e12013-02-13
0093-7442-56EA - Each0093-7442cca6cd74-ed04-44db-a2b7-04fb41f430b812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVASTATIN SODIUMACTIVE INGREDIENTPYF7O1FV7FFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
FLUVASTATINACTIVE MOIETY4L066368ASFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
GELATININACTIVE INGREDIENT2G86QN327LFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
SHELLACINACTIVE INGREDIENT46N107B71OFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7442FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 2 package rows20220721_aad8b373-0aec-4efb-8e61-3d8114b31127.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310404fluvastatin sodium 20 MG Oral CapsulePSNf5e8d1da-8911-42db-9f90-cba04b28d011102
310404fluvastatin 20 MG Oral CapsuleSCDf5e8d1da-8911-42db-9f90-cba04b28d011102
310404fluvastatin (as fluvastatin sodium) 20 MG Oral CapsuleSYf5e8d1da-8911-42db-9f90-cba04b28d011102
310404fluvastatin sodium 20 MG Oral CapsulePSNaad8b373-0aec-4efb-8e61-3d8114b3112712
310405fluvastatin sodium 40 MG Oral CapsulePSNaad8b373-0aec-4efb-8e61-3d8114b3112712
310404fluvastatin 20 MG Oral CapsuleSCDaad8b373-0aec-4efb-8e61-3d8114b3112712
310405fluvastatin 40 MG Oral CapsuleSCDaad8b373-0aec-4efb-8e61-3d8114b3112712
310404fluvastatin (as fluvastatin sodium) 20 MG Oral CapsuleSYaad8b373-0aec-4efb-8e61-3d8114b3112712
310405fluvastatin (as fluvastatin sodium) 40 MG Oral CapsuleSYaad8b373-0aec-4efb-8e61-3d8114b3112712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7442-0100093744201100 CAPSULE in 1 BOTTLE (0093-7442-01) 100 capsule2012-07-120000-00-00NoNoCurrent
0093-7442-560009374425630 CAPSULE in 1 BOTTLE (0093-7442-56) 30 capsule2012-07-050000-00-00NoNoCurrent