Fluvastatin

Product NDC
71335-2661
11-digit product format
713352661
Labeler code
71335
Product ID
71335-2661_17360f90-f600-4f72-ba3f-4efab90dea52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvastatin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078407
Marketing category
ANDA
Marketing start
2012-07-05
Substance
FLUVASTATIN SODIUM
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
Fluvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVASTATIN SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPYF7O1FV7F
Rxcui310405

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
71335-2661-1Fluvastatin100 in 1 BOTTLECAPSULE100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2661-1EA - Each71335-266121c9bcc4-4021-4540-922d-8fef99baef9712025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310405fluvastatin sodium 40 MG Oral CapsulePSN48801d7c-99ac-4a78-b714-299e2a5562ea100
310405fluvastatin 40 MG Oral CapsuleSCD48801d7c-99ac-4a78-b714-299e2a5562ea100
310405fluvastatin (as fluvastatin sodium) 40 MG Oral CapsuleSY48801d7c-99ac-4a78-b714-299e2a5562ea100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2661-171335266101100 CAPSULE in 1 BOTTLE (71335-2661-1) 100 capsule2025-06-26NoNoCurrent