FDA.reportPublic FDA data

Simvastatin

Product NDC
16714-683
11-digit product format
167140683
Labeler code
16714
Product ID
16714-683_6c353eba-27f3-43cc-b954-ec659881872f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA077691
Marketing category
ANDA
Marketing start
2006-12-20
Substance
SIMVASTATIN
Active strength
20 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
SIMVASTATIN20 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
16714-683-01Simvastatin30 in 1 BOTTLETABLET, FILM COATED3024
16714-683-02Simvastatin90 in 1 BOTTLETABLET, FILM COATED9024
16714-683-03Simvastatin1000 in 1 BOTTLETABLET, FILM COATED100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-683-01EA - Each16714-683f3d4a23e-5296-45d5-a136-3b86ee9b179f12012-07-24
16714-683-02EA - Each16714-6833df10d22-3540-4526-bce9-6b86a4fdbbdf12012-07-24
16714-683-03EA - Each16714-683bf85693f-a69d-452b-bcc4-babbd675f0f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-683SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]24Current NDC, Legacy NDC, 3 package rows20240425_0376351b-f1a0-43e5-a0b4-533072c49f39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN0376351b-f1a0-43e5-a0b4-533072c49f3924
312961simvastatin 20 MG Oral TabletPSN0376351b-f1a0-43e5-a0b4-533072c49f3924
198211simvastatin 40 MG Oral TabletPSN0376351b-f1a0-43e5-a0b4-533072c49f3924
312962simvastatin 5 MG Oral TabletPSN0376351b-f1a0-43e5-a0b4-533072c49f3924
200345simvastatin 80 MG Oral TabletPSN0376351b-f1a0-43e5-a0b4-533072c49f3924
314231simvastatin 10 MG Oral TabletSCD0376351b-f1a0-43e5-a0b4-533072c49f3924
312961simvastatin 20 MG Oral TabletSCD0376351b-f1a0-43e5-a0b4-533072c49f3924
198211simvastatin 40 MG Oral TabletSCD0376351b-f1a0-43e5-a0b4-533072c49f3924
312962simvastatin 5 MG Oral TabletSCD0376351b-f1a0-43e5-a0b4-533072c49f3924
200345simvastatin 80 MG Oral TabletSCD0376351b-f1a0-43e5-a0b4-533072c49f3924
312961simvastatin 20 MG Oral TabletPSN9133520e-1ffd-4ef1-bced-6b0c9a579f3912
312961simvastatin 20 MG Oral TabletSCD9133520e-1ffd-4ef1-bced-6b0c9a579f3912
312961simvastatin 20 MG Oral TabletPSN6de29f85-92e9-4a28-9bcc-6789f2f698de5
312961simvastatin 20 MG Oral TabletSCD6de29f85-92e9-4a28-9bcc-6789f2f698de5
312961simvastatin 20 MG Oral TabletPSNcf85b795-82fa-3389-e053-2995a90af2fd3
312961simvastatin 20 MG Oral TabletSCDcf85b795-82fa-3389-e053-2995a90af2fd3
312961simvastatin 20 MG Oral TabletPSN0a1fe17b-75d4-d361-e063-6394a90ae1882
312961simvastatin 20 MG Oral TabletSCD0a1fe17b-75d4-d361-e063-6394a90ae1882
312961simvastatin 20 MG Oral TabletPSNb9c315ff-cec9-8b75-e053-2995a90aa2041
312961simvastatin 20 MG Oral TabletPSNcc8258c3-6265-4b26-a1bf-df6476cc962a1
312961simvastatin 20 MG Oral TabletSCDb9c315ff-cec9-8b75-e053-2995a90aa2041
312961simvastatin 20 MG Oral TabletSCDcc8258c3-6265-4b26-a1bf-df6476cc962a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-683-011671406830130 TABLET, FILM COATED in 1 BOTTLE (16714-683-01) 2006-12-200000-00-00NoNoCurrent
16714-683-021671406830290 TABLET, FILM COATED in 1 BOTTLE (16714-683-02) 2006-12-200000-00-00NoNoCurrent
16714-683-03167140683031000 TABLET, FILM COATED in 1 BOTTLE (16714-683-03) 2006-12-200000-00-00NoNoCurrent