FDA.reportPublic FDA data

Simvastatin

Product NDC
50090-6389
11-digit product format
500906389
Labeler code
50090
Product ID
50090-6389_797f8859-cfed-4898-9ff0-d50971e0c7a3
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
20 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
SIMVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui312961

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6389-1Simvastatin30 in 1 BOTTLETABLET, FILM COATED301
50090-6389-2Simvastatin90 in 1 BOTTLETABLET, FILM COATED901
50090-6389-3Simvastatin200 in 1 BOTTLETABLET, FILM COATED2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6389-1EA - Each50090-638947adcaa6-abfd-4efd-860d-a45fef9aea9812023-04-07
50090-6389-2EA - Each50090-63899508aead-825f-454b-97e8-d18cba56ebf012023-04-07
50090-6389-3EA - Each50090-6389cd86cc09-ae4e-4ec3-8044-e72f38e678d712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6389SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230317_d09f88b5-b95f-4315-9b75-c09ce3d94397.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSNd09f88b5-b95f-4315-9b75-c09ce3d943971
312961simvastatin 20 MG Oral TabletSCDd09f88b5-b95f-4315-9b75-c09ce3d943971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6389-15009063890130 TABLET, FILM COATED in 1 BOTTLE (50090-6389-1) 2023-03-09NoNoCurrent
50090-6389-25009063890290 TABLET, FILM COATED in 1 BOTTLE (50090-6389-2) 2023-03-09NoNoCurrent
50090-6389-350090638903200 TABLET, FILM COATED in 1 BOTTLE (50090-6389-3) 2023-03-09NoNoCurrent