FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
68180-478
11-digit product format
681800478
Labeler code
68180
Product ID
68180-478_b78d4e8a-2261-43c6-9321-ac2539bdfd2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078103
Marketing category
ANDA
Marketing start
2007-06-12
Substance
SIMVASTATIN
Active strength
10 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
SIMVASTATIN10 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
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
68180-478-01SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED3023
68180-478-02SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED9023
68180-478-03SIMVASTATIN1000 in 1 BOTTLETABLET, FILM COATED100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-478-01EA - Each68180-478d0306c5b-d990-4ceb-b5ce-726978c4918212012-07-24
68180-478-02EA - Each68180-478af9b4ecd-2ecf-4bf0-9c41-47b77c463b0e12012-07-24
68180-478-03EA - Each68180-478707f9be1-c31a-4001-9d2c-c227f415cc9b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-478SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 3 package rows20250515_3e48217f-8175-4e9b-9fd0-909be4bbba95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN76ea62f3-4efb-4649-829d-3f0c28d5dae7103
314231simvastatin 10 MG Oral TabletSCD76ea62f3-4efb-4649-829d-3f0c28d5dae7103
314231simvastatin 10 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
312961simvastatin 20 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
198211simvastatin 40 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
312962simvastatin 5 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
200345simvastatin 80 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
314231simvastatin 10 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
312961simvastatin 20 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
198211simvastatin 40 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
312962simvastatin 5 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
200345simvastatin 80 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
314231simvastatin 10 MG Oral TabletPSN25d9f841-31d8-4514-ac73-ffe138ff69c719
314231simvastatin 10 MG Oral TabletSCD25d9f841-31d8-4514-ac73-ffe138ff69c719
314231simvastatin 10 MG Oral TabletPSN1ddc0230-24ab-4e69-9c6c-6776c354c82c17
312961simvastatin 20 MG Oral TabletPSN1ddc0230-24ab-4e69-9c6c-6776c354c82c17
314231simvastatin 10 MG Oral TabletSCD1ddc0230-24ab-4e69-9c6c-6776c354c82c17
312961simvastatin 20 MG Oral TabletSCD1ddc0230-24ab-4e69-9c6c-6776c354c82c17
314231simvastatin 10 MG Oral TabletPSN5ae78a86-ccca-4714-b77e-7bc885b674b516
314231simvastatin 10 MG Oral TabletSCD5ae78a86-ccca-4714-b77e-7bc885b674b516
314231simvastatin 10 MG Oral TabletPSN4bec3923-6221-4b8b-9a72-872a63680de113
312961simvastatin 20 MG Oral TabletPSN4bec3923-6221-4b8b-9a72-872a63680de113
314231simvastatin 10 MG Oral TabletSCD4bec3923-6221-4b8b-9a72-872a63680de113
312961simvastatin 20 MG Oral TabletSCD4bec3923-6221-4b8b-9a72-872a63680de113
314231simvastatin 10 MG Oral TabletPSN673dfc44-d407-f9ac-e053-2a91aa0a47025
314231simvastatin 10 MG Oral TabletPSNe4d8ebf3-7f9f-4725-a104-1d1bf6e6f7685
314231simvastatin 10 MG Oral TabletSCDe4d8ebf3-7f9f-4725-a104-1d1bf6e6f7685
314231simvastatin 10 MG Oral TabletSCD673dfc44-d407-f9ac-e053-2a91aa0a47025
314231simvastatin 10 MG Oral TabletPSN0ccb324f-877d-4f32-a769-7cd1637b7fad4
314231simvastatin 10 MG Oral TabletPSN0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
312961simvastatin 20 MG Oral TabletPSN0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
198211simvastatin 40 MG Oral TabletPSN0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
314231simvastatin 10 MG Oral TabletSCD0ccb324f-877d-4f32-a769-7cd1637b7fad4
314231simvastatin 10 MG Oral TabletSCD0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
312961simvastatin 20 MG Oral TabletSCD0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
198211simvastatin 40 MG Oral TabletSCD0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
314231simvastatin 10 MG Oral TabletPSN7e3fc83f-e322-44a1-b0c3-30e6292b92d93
314231simvastatin 10 MG Oral TabletPSNe73ec981-e477-4412-befd-7b807aceb32e3
312961simvastatin 20 MG Oral TabletPSN7e3fc83f-e322-44a1-b0c3-30e6292b92d93
198211simvastatin 40 MG Oral TabletPSN7e3fc83f-e322-44a1-b0c3-30e6292b92d93
314231simvastatin 10 MG Oral TabletSCD7e3fc83f-e322-44a1-b0c3-30e6292b92d93
314231simvastatin 10 MG Oral TabletSCDe73ec981-e477-4412-befd-7b807aceb32e3
312961simvastatin 20 MG Oral TabletSCD7e3fc83f-e322-44a1-b0c3-30e6292b92d93
198211simvastatin 40 MG Oral TabletSCD7e3fc83f-e322-44a1-b0c3-30e6292b92d93
314231simvastatin 10 MG Oral TabletPSNf7aa095f-590c-98e3-e053-6394a90ad9722
314231simvastatin 10 MG Oral TabletSCDf7aa095f-590c-98e3-e053-6394a90ad9722
314231simvastatin 10 MG Oral TabletPSN50733b85-067d-99c3-e063-6394a90a42441
314231simvastatin 10 MG Oral TabletPSNdad0dd7d-3049-4be4-aaeb-8a1895d552081
314231simvastatin 10 MG Oral TabletPSN450e722c-d55d-3e6d-e063-6394a90a52311
314231simvastatin 10 MG Oral TabletSCD50733b85-067d-99c3-e063-6394a90a42441
314231simvastatin 10 MG Oral TabletSCDdad0dd7d-3049-4be4-aaeb-8a1895d552081
314231simvastatin 10 MG Oral TabletSCD450e722c-d55d-3e6d-e063-6394a90a52311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-478-016818004780130 TABLET, FILM COATED in 1 BOTTLE (68180-478-01) 2007-06-120000-00-00NoNoCurrent
68180-478-026818004780290 TABLET, FILM COATED in 1 BOTTLE (68180-478-02) 2007-06-120000-00-00NoNoCurrent
68180-478-03681800478031000 TABLET, FILM COATED in 1 BOTTLE (68180-478-03) 2007-06-120000-00-00NoNoCurrent