FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
51655-387
11-digit product format
516550387
Labeler code
51655
Product ID
51655-387_49db4d1f-7b69-8723-e063-6294a90acc03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078103
Marketing category
ANDA
Marketing start
2023-03-28
Substance
SIMVASTATIN
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
SIMVASTATIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui198211

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-387-262026-01-29C16284748780-149896155-b745-586f-e063-e6dba90add90These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
51655-387-522026-01-29C16284748780-149896155-b745-586f-e063-e6dba90add90These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-387-26SIMVASTATIN90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
51655-387-52SIMVASTATIN30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-387SIMVASTATIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240723_f835af8f-7d84-1978-e053-6294a90a22ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSNf835af8f-7d84-1978-e053-6294a90a22ae3
198211simvastatin 40 MG Oral TabletSCDf835af8f-7d84-1978-e053-6294a90a22ae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-387-265165503872690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-387-26) 2023-03-28NoNoCurrent
51655-387-525165503875230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-387-52) 2023-03-28NoNoCurrent