FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
68180-479
11-digit product format
681800479
Labeler code
68180
Product ID
68180-479_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
2007-06-14
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
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
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
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
68180-479-01SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED3023
68180-479-02SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED9023
68180-479-03SIMVASTATIN1000 in 1 BOTTLETABLET, FILM COATED100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-479-01EA - Each68180-47916486cdb-cf64-4255-a615-d9555f5e476b12012-07-24
68180-479-02EA - Each68180-4790e70317f-4f1e-44c9-bedf-36aa91b01d1512012-07-24
68180-479-03EA - Each68180-479e2ed0711-ff7a-4871-86dc-22d107994c0c12012-07-24

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
68180-479SIMVASTATIN 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
312961simvastatin 20 MG Oral TabletPSN5c760852-800b-463e-8059-06a9a82c2225104
312961simvastatin 20 MG Oral TabletSCD5c760852-800b-463e-8059-06a9a82c2225104
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
312961simvastatin 20 MG Oral TabletPSN143bf1d6-11c5-4a1f-b106-844e0435ee1320
312961simvastatin 20 MG Oral TabletSCD143bf1d6-11c5-4a1f-b106-844e0435ee1320
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 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
312961simvastatin 20 MG Oral TabletPSN30fe2447-4dd3-43e6-bac5-0f754ab77c3a5
312961simvastatin 20 MG Oral TabletPSNf71fc0ac-223e-18c1-e053-6394a90a45ca5
312961simvastatin 20 MG Oral TabletSCDf71fc0ac-223e-18c1-e053-6394a90a45ca5
312961simvastatin 20 MG Oral TabletSCD30fe2447-4dd3-43e6-bac5-0f754ab77c3a5
314231simvastatin 10 MG Oral TabletPSN0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
312961simvastatin 20 MG Oral TabletPSNf42246de-62d2-212f-e053-2a95a90ac88a4
312961simvastatin 20 MG Oral TabletPSNa53cfdd8-ca99-47a9-827d-1b06a03298784
312961simvastatin 20 MG Oral TabletPSN0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
312961simvastatin 20 MG Oral TabletPSNf86de805-e4ec-4bca-e053-6294a90a1fc34
198211simvastatin 40 MG Oral TabletPSN0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
314231simvastatin 10 MG Oral TabletSCD0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
312961simvastatin 20 MG Oral TabletSCDf42246de-62d2-212f-e053-2a95a90ac88a4
312961simvastatin 20 MG Oral TabletSCD0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
312961simvastatin 20 MG Oral TabletSCDf86de805-e4ec-4bca-e053-6294a90a1fc34
312961simvastatin 20 MG Oral TabletSCDa53cfdd8-ca99-47a9-827d-1b06a03298784
198211simvastatin 40 MG Oral TabletSCD0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
314231simvastatin 10 MG Oral TabletPSN7e3fc83f-e322-44a1-b0c3-30e6292b92d93
312961simvastatin 20 MG Oral TabletPSN3f6fad0b-0278-433f-86db-761b673a58033
312961simvastatin 20 MG Oral TabletPSN7e3fc83f-e322-44a1-b0c3-30e6292b92d93
312961simvastatin 20 MG Oral TabletPSN8e686832-1caf-425c-9ca6-7eaade43b6fe3
312961simvastatin 20 MG Oral TabletPSN09fa512b-f6c1-437d-be46-a8ddd36743b43
198211simvastatin 40 MG Oral TabletPSN7e3fc83f-e322-44a1-b0c3-30e6292b92d93
314231simvastatin 10 MG Oral TabletSCD7e3fc83f-e322-44a1-b0c3-30e6292b92d93
312961simvastatin 20 MG Oral TabletSCD7e3fc83f-e322-44a1-b0c3-30e6292b92d93
312961simvastatin 20 MG Oral TabletSCD8e686832-1caf-425c-9ca6-7eaade43b6fe3
312961simvastatin 20 MG Oral TabletSCD3f6fad0b-0278-433f-86db-761b673a58033
312961simvastatin 20 MG Oral TabletSCD09fa512b-f6c1-437d-be46-a8ddd36743b43
198211simvastatin 40 MG Oral TabletSCD7e3fc83f-e322-44a1-b0c3-30e6292b92d93
312961simvastatin 20 MG Oral TabletPSNf7805136-6e35-eb84-e053-6294a90a9e5d1
312961simvastatin 20 MG Oral TabletPSNfaa81817-3ffa-b83c-e053-6294a90a3f851
312961simvastatin 20 MG Oral TabletPSN5257271e-5c07-4996-e063-6394a90a44241
312961simvastatin 20 MG Oral TabletPSN03b21156-9086-0fcf-e063-6294a90aa64a1
312961simvastatin 20 MG Oral TabletSCDf7805136-6e35-eb84-e053-6294a90a9e5d1
312961simvastatin 20 MG Oral TabletSCD5257271e-5c07-4996-e063-6394a90a44241
312961simvastatin 20 MG Oral TabletSCDfaa81817-3ffa-b83c-e053-6294a90a3f851
312961simvastatin 20 MG Oral TabletSCD03b21156-9086-0fcf-e063-6294a90aa64a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-479-016818004790130 TABLET, FILM COATED in 1 BOTTLE (68180-479-01) 2007-06-140000-00-00NoNoCurrent
68180-479-026818004790290 TABLET, FILM COATED in 1 BOTTLE (68180-479-02) 2007-06-140000-00-00NoNoCurrent
68180-479-03681800479031000 TABLET, FILM COATED in 1 BOTTLE (68180-479-03) 2007-06-140000-00-00NoNoCurrent