FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
50090-6306
11-digit product format
500906306
Labeler code
50090
Product ID
50090-6306_4cd7b09e-0400-4dbe-83a9-f2f5554a7ee9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078103
Marketing category
ANDA
Marketing start
2007-06-14
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50090-6306-1SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED303
50090-6306-2SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED903
50090-6306-3SIMVASTATIN200 in 1 BOTTLETABLET, FILM COATED2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6306-1EA - Each50090-63068108ce55-17b5-42fd-8bf5-c1062453f9da12023-02-06
50090-6306-2EA - Each50090-6306277d8c69-8700-48cf-b78a-ecd35dc908cc12023-02-06
50090-6306-3EA - Each50090-630679102d56-20fd-4064-b829-ffe46d5d210612023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6306SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, Legacy NDC, 3 package rows20230105_09fa512b-f6c1-437d-be46-a8ddd36743b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSN09fa512b-f6c1-437d-be46-a8ddd36743b43
312961simvastatin 20 MG Oral TabletSCD09fa512b-f6c1-437d-be46-a8ddd36743b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6306-15009063060130 TABLET, FILM COATED in 1 BOTTLE (50090-6306-1) 2022-12-290000-00-00NoNoCurrent
50090-6306-25009063060290 TABLET, FILM COATED in 1 BOTTLE (50090-6306-2) 2022-12-290000-00-00NoNoCurrent
50090-6306-350090630603200 TABLET, FILM COATED in 1 BOTTLE (50090-6306-3) 2022-12-290000-00-00NoNoCurrent