FDA.reportPublic FDA data

Simvastatin

Product NDC
31722-513
11-digit product format
317220513
Labeler code
31722
Product ID
31722-513_1553d57f-414d-2c66-e063-6294a90af8e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA200895
Marketing category
ANDA
Marketing start
2014-12-03
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
31722-513-01Simvastatin100 in 1 BOTTLETABLET, FILM COATED10010
31722-513-10Simvastatin1000 in 1 BOTTLETABLET, FILM COATED100010
31722-513-30Simvastatin30 in 1 BOTTLETABLET, FILM COATED3010
31722-513-90Simvastatin90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-513-10EA - Each31722-51332adf5e7-91bb-454b-8a92-4f989002a2ed12016-04-04
31722-513-90EA - Each31722-513a4ad64c4-f54a-4f11-af61-6fb3fd35227212016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
HYDROXYPROPYL CELLULOSE (Type H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-513SIMVASTATIN (SIMVASTATIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 4 package rows20240406_751b79c6-bba8-4d29-b69c-a2ac6453fec8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN751b79c6-bba8-4d29-b69c-a2ac6453fec810
312961simvastatin 20 MG Oral TabletPSN751b79c6-bba8-4d29-b69c-a2ac6453fec810
198211simvastatin 40 MG Oral TabletPSN751b79c6-bba8-4d29-b69c-a2ac6453fec810
312962simvastatin 5 MG Oral TabletPSN751b79c6-bba8-4d29-b69c-a2ac6453fec810
200345simvastatin 80 MG Oral TabletPSN751b79c6-bba8-4d29-b69c-a2ac6453fec810
314231simvastatin 10 MG Oral TabletSCD751b79c6-bba8-4d29-b69c-a2ac6453fec810
312961simvastatin 20 MG Oral TabletSCD751b79c6-bba8-4d29-b69c-a2ac6453fec810
198211simvastatin 40 MG Oral TabletSCD751b79c6-bba8-4d29-b69c-a2ac6453fec810
312962simvastatin 5 MG Oral TabletSCD751b79c6-bba8-4d29-b69c-a2ac6453fec810
200345simvastatin 80 MG Oral TabletSCD751b79c6-bba8-4d29-b69c-a2ac6453fec810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-513-0131722051301100 TABLET, FILM COATED in 1 BOTTLE (31722-513-01) 2014-12-030000-00-00NoNoCurrent
31722-513-10317220513101000 TABLET, FILM COATED in 1 BOTTLE (31722-513-10) 2014-12-030000-00-00NoNoCurrent
31722-513-303172205133030 TABLET, FILM COATED in 1 BOTTLE (31722-513-30) 2014-12-030000-00-00NoNoCurrent
31722-513-903172205139090 TABLET, FILM COATED in 1 BOTTLE (31722-513-90) 2014-12-030000-00-00NoNoCurrent