FDA.reportPublic FDA data

Simvastatin

Product NDC
72865-309
11-digit product format
728650309
Labeler code
72865
Product ID
72865-309_48bd010d-6429-906e-e063-6394a90ae8b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA200895
Marketing category
ANDA
Marketing start
2026-01-21
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
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
SIMVASTATIN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui198211, 200345, 312961, 312962, 314231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
72865-309-01Simvastatin100 in 1 BOTTLETABLET, FILM COATED1001
72865-309-05Simvastatin500 in 1 BOTTLETABLET, FILM COATED5001
72865-309-10Simvastatin1000 in 1 BOTTLETABLET, FILM COATED10001
72865-309-30Simvastatin30 in 1 BOTTLETABLET, FILM COATED301
72865-309-45Simvastatin45 in 1 BOTTLETABLET, FILM COATED451
72865-309-90Simvastatin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN433f8a86-5ad3-43db-8e62-c0812dd3d7231
312961simvastatin 20 MG Oral TabletPSN433f8a86-5ad3-43db-8e62-c0812dd3d7231
198211simvastatin 40 MG Oral TabletPSN433f8a86-5ad3-43db-8e62-c0812dd3d7231
312962simvastatin 5 MG Oral TabletPSN433f8a86-5ad3-43db-8e62-c0812dd3d7231
200345simvastatin 80 MG Oral TabletPSN433f8a86-5ad3-43db-8e62-c0812dd3d7231
314231simvastatin 10 MG Oral TabletSCD433f8a86-5ad3-43db-8e62-c0812dd3d7231
312961simvastatin 20 MG Oral TabletSCD433f8a86-5ad3-43db-8e62-c0812dd3d7231
198211simvastatin 40 MG Oral TabletSCD433f8a86-5ad3-43db-8e62-c0812dd3d7231
312962simvastatin 5 MG Oral TabletSCD433f8a86-5ad3-43db-8e62-c0812dd3d7231
200345simvastatin 80 MG Oral TabletSCD433f8a86-5ad3-43db-8e62-c0812dd3d7231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72865-309-0172865030901100 TABLET, FILM COATED in 1 BOTTLE (72865-309-01) 2026-01-21NoNoCurrent
72865-309-0572865030905500 TABLET, FILM COATED in 1 BOTTLE (72865-309-05) 2026-01-21NoNoCurrent
72865-309-10728650309101000 TABLET, FILM COATED in 1 BOTTLE (72865-309-10) 2026-01-21NoNoCurrent
72865-309-307286503093030 TABLET, FILM COATED in 1 BOTTLE (72865-309-30) 2026-01-21NoNoCurrent
72865-309-457286503094545 TABLET, FILM COATED in 1 BOTTLE (72865-309-45) 2026-01-21NoNoCurrent
72865-309-907286503099090 TABLET, FILM COATED in 1 BOTTLE (72865-309-90) 2026-01-21NoNoCurrent