FDA.reportPublic FDA data

Simvastatin

Product NDC
50090-7088
11-digit product format
500907088
Labeler code
50090
Product ID
50090-7088_6c69353b-17c8-4faf-a68f-0326903ba63a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077691
Marketing category
ANDA
Marketing start
2006-12-20
Substance
SIMVASTATIN
Active strength
80 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
Simvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui200345

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7088-0Simvastatin30 in 1 BOTTLETABLET, FILM COATED301
50090-7088-1Simvastatin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7088-0EA - Each50090-7088096b988a-4111-465f-972c-0cefe0ac46ea12024-03-12
50090-7088-1EA - Each50090-7088a6ab36e3-9658-4d53-886c-dcfc8802127512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7088SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240217_2e579278-c105-4cda-92ca-a3496d846c82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200345simvastatin 80 MG Oral TabletPSN2e579278-c105-4cda-92ca-a3496d846c821
200345simvastatin 80 MG Oral TabletSCD2e579278-c105-4cda-92ca-a3496d846c821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7088-05009070880030 TABLET, FILM COATED in 1 BOTTLE (50090-7088-0) 2024-02-12NoNoCurrent
50090-7088-15009070880190 TABLET, FILM COATED in 1 BOTTLE (50090-7088-1) 2024-02-09NoNoCurrent