FDA.reportPublic FDA data

Simvastatin

Product NDC
42571-040
11-digit product format
425710040
Labeler code
42571
Product ID
42571-040_0369d423-9ef2-0191-e063-6294a90a55e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA090383
Marketing category
ANDA
Marketing start
2013-06-13
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, 200345, 312961, 312962, 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
42571-040-05Simvastatin500 in 1 BOTTLETABLET50090400
42571-040-10Simvastatin1000 in 1 BOTTLETABLET100090400
42571-040-30Simvastatin30 in 1 BOTTLETABLET3090400
42571-040-60Simvastatin60 in 1 BOTTLETABLET6090400
42571-040-90Simvastatin90 in 1 BOTTLETABLET9090400

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-040-10EA - Each42571-040e8e433a7-cd97-4e1c-9219-21e90221a7f412013-04-01
42571-040-90EA - Each42571-0400ef15796-7240-4a26-b079-22a2f40e9df512013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET [MICRO LABS LIMITED]90388
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET [MICRO LABS LIMITED]90388
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SIMVASTATIN TABLET [MICRO LABS LIMITED]90388
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET [MICRO LABS LIMITED]90388
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET [MICRO LABS LIMITED]90388
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET [MICRO LABS LIMITED]90388

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-040SIMVASTATIN (SIMVASTATIN) TABLET [MICRO LABS LIMITED]90400Current NDC, Legacy NDC, 5 package rows20230822_5c1c694c-4b08-469e-b538-08e69df06146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN5c1c694c-4b08-469e-b538-08e69df0614690400
312961simvastatin 20 MG Oral TabletPSN5c1c694c-4b08-469e-b538-08e69df0614690400
198211simvastatin 40 MG Oral TabletPSN5c1c694c-4b08-469e-b538-08e69df0614690400
312962simvastatin 5 MG Oral TabletPSN5c1c694c-4b08-469e-b538-08e69df0614690400
200345simvastatin 80 MG Oral TabletPSN5c1c694c-4b08-469e-b538-08e69df0614690400
314231simvastatin 10 MG Oral TabletSCD5c1c694c-4b08-469e-b538-08e69df0614690400
312961simvastatin 20 MG Oral TabletSCD5c1c694c-4b08-469e-b538-08e69df0614690400
198211simvastatin 40 MG Oral TabletSCD5c1c694c-4b08-469e-b538-08e69df0614690400
312962simvastatin 5 MG Oral TabletSCD5c1c694c-4b08-469e-b538-08e69df0614690400
200345simvastatin 80 MG Oral TabletSCD5c1c694c-4b08-469e-b538-08e69df0614690400

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-040-0542571004005500 TABLET in 1 BOTTLE (42571-040-05) 500 tablet2013-06-130000-00-00NoNoCurrent
42571-040-10425710040101000 TABLET in 1 BOTTLE (42571-040-10) 1000 tablet2013-06-130000-00-00NoNoCurrent
42571-040-304257100403030 TABLET in 1 BOTTLE (42571-040-30) 30 tablet2013-06-130000-00-00NoNoCurrent
42571-040-604257100406060 TABLET in 1 BOTTLE (42571-040-60) 60 tablet2013-06-130000-00-00NoNoCurrent
42571-040-904257100409090 TABLET in 1 BOTTLE (42571-040-90) 90 tablet2013-06-130000-00-00NoNoCurrent