FDA.reportPublic FDA data

Fluvastatin Sodium

Product NDC
0527-2580
11-digit product format
005272580
Labeler code
0527
Product ID
0527-2580_4d56c57e-1d38-e010-e063-6294a90a8c83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvastatin Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA209397
Marketing category
ANDA
Marketing start
2021-05-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluvastatin Sodium
Listing expiration
2027-12-31

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
0527-2580-32Fluvastatin Sodium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3013
0527-2580-37Fluvastatin Sodium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-2580-32EA - Each0527-25805f6cf9e7-9ef8-4181-a0c5-02cfa4e027fe12021-07-15
0527-2580-37EA - Each0527-258047571e01-bef5-48e7-a736-0a78fa94fa3f12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-2580FLUVASTATIN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [LANNETT COMPANY, INC.]11Current NDC, Legacy NDC, 2 package rows20240719_3565bfd3-ef9f-456d-b4be-a294a7a0f01c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360507fluvastatin sodium 80 MG 24HR Extended Release Oral TabletPSN3565bfd3-ef9f-456d-b4be-a294a7a0f01c13
36050724 HR fluvastatin 80 MG Extended Release Oral TabletSCD3565bfd3-ef9f-456d-b4be-a294a7a0f01c13
360507fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral TabletSY3565bfd3-ef9f-456d-b4be-a294a7a0f01c13
360507fluvastatin 80 MG 24 HR Extended Release Oral TabletSY3565bfd3-ef9f-456d-b4be-a294a7a0f01c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-2580-320052725803230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-32) 2021-05-070000-00-00NoNoCurrent
0527-2580-3700527258037100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-37) 2022-03-140000-00-00NoNoCurrent