Fluvastatin

Product NDC
72162-1034
11-digit product format
721621034
Labeler code
72162
Product ID
72162-1034_ab031304-c267-4183-9378-39ec4728dbd9
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
72162-1034-1Fluvastatin100 in 1 BOTTLECAPSULE100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1034-1EA - Each72162-10348c37cf78-45ff-459d-8965-52c57be661cf12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1034FLUVASTATIN CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240517_ccd6bbe1-e293-4e1c-9ec4-e6c217612e77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310405fluvastatin sodium 40 MG Oral CapsulePSNccd6bbe1-e293-4e1c-9ec4-e6c217612e77101
310405fluvastatin 40 MG Oral CapsuleSCDccd6bbe1-e293-4e1c-9ec4-e6c217612e77101
310405fluvastatin (as fluvastatin sodium) 40 MG Oral CapsuleSYccd6bbe1-e293-4e1c-9ec4-e6c217612e77101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1034-172162103401100 CAPSULE in 1 BOTTLE (72162-1034-1) 100 capsule2024-05-16NoNoHistorical