Fluvastatin

Product NDC
63629-8737
11-digit product format
636298737
Labeler code
63629
Product ID
63629-8737_873de640-2891-4a4d-a2bb-cb55a13cd519
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
63629-8737-1Fluvastatin100 in 1 BOTTLECAPSULE100105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8737-1EA - Each63629-87377e75dbff-823f-4631-9f8f-51510d20c6c712021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8737FLUVASTATIN CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20250519_e3c9f49c-051c-451a-8749-1a7bee820078.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310405fluvastatin sodium 40 MG Oral CapsulePSNe3c9f49c-051c-451a-8749-1a7bee820078105
310405fluvastatin 40 MG Oral CapsuleSCDe3c9f49c-051c-451a-8749-1a7bee820078105
310405fluvastatin (as fluvastatin sodium) 40 MG Oral CapsuleSYe3c9f49c-051c-451a-8749-1a7bee820078105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8737-163629873701100 CAPSULE in 1 BOTTLE (63629-8737-1) 100 capsule2021-08-190000-00-00NoNoCurrent