FDA.reportPublic FDA data

Simvastatin

Product NDC
68071-3530
11-digit product format
680713530
Labeler code
68071
Product ID
68071-3530_2d3f9083-458e-6f8d-e063-6394a90a032b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3530-92025-02-03C16284748780-12cef2736-6c40-d83d-e063-dadaa90ab31fThese 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
68071-3530-92025-01-30C16284748780-12cef2736-6c40-d83d-e063-dadaa90ab31fThese 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
68071-3530-9Simvastatin90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3530SIMVASTATIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250205_0a1fe17b-75d4-d361-e063-6394a90ae188.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSN0a1fe17b-75d4-d361-e063-6394a90ae1882
312961simvastatin 20 MG Oral TabletSCD0a1fe17b-75d4-d361-e063-6394a90ae1882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3530-96807135300990 TABLET, FILM COATED in 1 BOTTLE (68071-3530-9) 2023-11-14NoNoCurrent