FDA.reportPublic FDA data

Simvastatin

Product NDC
60687-210
11-digit product format
606870210
Labeler code
60687
Product ID
60687-210_35938edc-f896-cc85-e063-6394a90ab210
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078103
Marketing category
ANDA
Marketing start
2016-06-08
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
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
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
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
60687-210-01Simvastatin100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10011
60687-210-11Simvastatin1 in 1 BLISTER PACKTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-210-01EA - Each60687-2102f297ce0-ad4e-420d-9ace-0ba02222376b12016-07-19
60687-210-11EA - Each60687-2108d37bd56-4928-4b3c-ae30-a8803df6b8cb12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-210SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20250522_51dd8d34-e660-49dc-a86e-07d031a18465.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSN51dd8d34-e660-49dc-a86e-07d031a1846511
198211simvastatin 40 MG Oral TabletSCD51dd8d34-e660-49dc-a86e-07d031a1846511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-210-0160687021001100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-210-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-210-11) 100 blister pack2016-06-080000-00-00NoNoCurrent
60687-210-11606870210111 in 1 BLISTER PACKHistorical