FDA.reportPublic FDA data

Simvastatin

Product NDC
69367-377
11-digit product format
693670377
Labeler code
69367
Product ID
69367-377_5bcccfd7-0ae8-4fad-a535-5efa7b327550
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA211394
Marketing category
ANDA
Marketing start
2025-04-14
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
Rxcui198211, 200345, 312961, 314231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
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
69367-377-09Simvastatin90 in 1 BOTTLETABLET, FILM COATED902
69367-377-10Simvastatin1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-377SIMVASTATIN TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20250423_acaaab63-c9ff-44c9-8fde-9a4ea6454dd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNacaaab63-c9ff-44c9-8fde-9a4ea6454dd72
312961simvastatin 20 MG Oral TabletPSNacaaab63-c9ff-44c9-8fde-9a4ea6454dd72
198211simvastatin 40 MG Oral TabletPSNacaaab63-c9ff-44c9-8fde-9a4ea6454dd72
200345simvastatin 80 MG Oral TabletPSNacaaab63-c9ff-44c9-8fde-9a4ea6454dd72
314231simvastatin 10 MG Oral TabletSCDacaaab63-c9ff-44c9-8fde-9a4ea6454dd72
312961simvastatin 20 MG Oral TabletSCDacaaab63-c9ff-44c9-8fde-9a4ea6454dd72
198211simvastatin 40 MG Oral TabletSCDacaaab63-c9ff-44c9-8fde-9a4ea6454dd72
200345simvastatin 80 MG Oral TabletSCDacaaab63-c9ff-44c9-8fde-9a4ea6454dd72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-377-096936703770990 TABLET, FILM COATED in 1 BOTTLE (69367-377-09) 2025-04-14NoNoCurrent
69367-377-10693670377101000 TABLET, FILM COATED in 1 BOTTLE (69367-377-10) 2025-04-14NoNoCurrent