NDC 16729-006-12 - simvastatin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
16729-006
Requested NDC
16729-006-12
Package NDCs from labels
16729-006-10, 16729-006-12, 16729-006-15, 16729-006-17
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
simvastatin - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2026-05-12HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Accord Healthcare, Inc. | Intas Pharmaceuticals Limited.Accord Healthcare, Inc. | Intas Pharmaceuticals Limited.2025-11-14HUMAN PRESCRIPTION DRUG LABEL
SIMVASTATIN - St Marys Medical Park PharmacySt Marys Medical Park Pharmacy2024-12-11HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2024-08-09HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Bryant Ranch PrepackBryant Ranch Prepack2024-08-08HUMAN PRESCRIPTION DRUG LABEL
simvastatin - REMEDYREPACK INC.REMEDYREPACK INC.2024-07-26HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc. | NuCare Pharmaceuticals Inc..NuCare Pharmaceuticals,Inc. | NuCare Pharmaceuticals Inc..2024-07-15HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-18HUMAN PRESCRIPTION DRUG LABEL
simvastatin - A-S Medication SolutionsA-S Medication Solutions2024-01-11HUMAN PRESCRIPTION DRUG LABEL
simvastatin - REMEDYREPACK INC.REMEDYREPACK INC.2023-08-08HUMAN PRESCRIPTION DRUG LABEL
simvastatin - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
SIMVASTATIN - DIRECT RXDIRECT RX2023-01-12HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Proficient Rx LPProficient Rx LP2022-05-01HUMAN PRESCRIPTION DRUG LABEL
simvastatin - A-S Medication SolutionsA-S Medication Solutions2021-05-18HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2021-04-27HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2021-02-23HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-02-17HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Bryant Ranch PrepackBryant Ranch Prepack2020-07-07HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2020-06-17HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2019-08-19HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Contract Pharmacy Services-PA | Coupler EnterprisesContract Pharmacy Services-PA | Coupler Enterprises2018-12-29HUMAN PRESCRIPTION DRUG LABEL
simvastatin - KAISER FOUNDATION HOSPITALSKAISER FOUNDATION HOSPITALS2018-11-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-006-10simvastatin30 in 1 BOTTLETABLET, FILM COATED3022
16729-006-12simvastatin60 in 1 BOTTLETABLET, FILM COATED6022
16729-006-15simvastatin90 in 1 BOTTLETABLET, FILM COATED9022
16729-006-17simvastatin1000 in 1 BOTTLETABLET, FILM COATED100022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-006SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]21Current NDC, Legacy NDC, 4 package rows20240719_871251c0-36a1-4a32-9eab-ff6c1e925ca9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-006-10EA - Each16729-006f02fdbe2-2f0c-485f-8667-f02eaa0790f112012-07-24
16729-006-15EA - Each16729-006ede33287-7ce7-447b-9196-ce3b838b06f012012-07-24
16729-006-17EA - Each16729-0064604fbf5-b253-441d-b5be-f57a7eb8e52a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [READYMEDS]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [READYMEDS]11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [READYMEDS]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [READYMEDS]11
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [READYMEDS]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [READYMEDS]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [READYMEDS]11
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4SIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [DIRECT RX]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]5
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]3
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]1
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]1
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 125 · 2,486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimvastatinSIMVASTATINREMEDYREPACK INC.d053fee4-b797-4a82-8865-0b4d08b149902026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 312961
unii: AGG2FN16EV
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERREMEDYREPACK INC.5d67a268-437b-403d-9d05-6524c4a7c4992026-08-11WarningsExact identifier
unii: PQ6CK8PD0R
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC58cd6c9a-3429-24eb-e063-6394a90a69842026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 198211
unii: AGG2FN16EV
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SIMVASTATINSIMVASTATINREMEDYREPACK INC.e59bf31f-d880-4d9e-b6c2-5a18a53718f92026-08-06Warnings, Adverse reactionsExact identifier
application number: ANDA078103
rxcui: 198211
unii: AGG2FN16EV
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.