NDC 16729-005-12 - 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: 16729-005
Requested NDC: 16729-005-12
Package NDCs from labels: 16729-005-10, 16729-005-12, 16729-005-15, 16729-005-17
Manufacturer: QPharma, Inc. | Accord Healthcare, Inc. | Northwind Health Company, LLC
Effective date: 2025-12-03
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
simvastatin - QPharma, Inc. \| Accord Healthcare, Inc. \| Northwind Health Company, LLC	QPharma, Inc. \| Accord Healthcare, Inc. \| Northwind Health Company, LLC	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Accord Healthcare, Inc. \| Intas Pharmaceuticals Limited.	Accord Healthcare, Inc. \| Intas Pharmaceuticals Limited.	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL
SIMVASTATIN - St Marys Medical Park Pharmacy	St Marys Medical Park Pharmacy	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - A-S Medication Solutions	A-S Medication Solutions	2024-11-25	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Preferred Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - REMEDYREPACK INC.	REMEDYREPACK INC.	2024-07-26	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2023-09-19	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - A-S Medication Solutions	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL
SIMVASTATIN - Direct Rx	Direct Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Proficient Rx LP	Proficient Rx LP	2022-05-01	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc.	2021-03-31	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Contract Pharmacy Services-PA \| Coupler Enterprises	Contract Pharmacy Services-PA \| Coupler Enterprises	2018-12-29	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - KAISER FOUNDATION HOSPITALS	KAISER FOUNDATION HOSPITALS	2018-11-19	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2018-04-26	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2018-02-27	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Unit Dose Services	Unit Dose Services	2017-07-01	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Blenheim Pharmacal, Inc.	Blenheim Pharmacal, Inc.	2015-11-25	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - RxChange Co.	RxChange Co.	2014-11-20	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2014-09-30	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-005-10	simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
16729-005-12	simvastatin	60 in 1 BOTTLE	TABLET, FILM COATED	60	22
16729-005-15	simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	22
16729-005-17	simvastatin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-005	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	21	Current NDC, Legacy NDC, 4 package rows	20240719_871251c0-36a1-4a32-9eab-ff6c1e925ca9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-005-10	EA - Each	16729-005	a62bd48a-6b38-4504-ba24-1d78d2ee6973	1	2012-07-24
16729-005-15	EA - Each	16729-005	96ac1649-092f-4666-ab20-8382a979c3d8	1	2012-07-24
16729-005-17	EA - Each	16729-005	ad81b062-50d8-4875-9e2b-b207afc1962c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	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 8 of 125 · 2,487 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACD A	CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE	Terumo BCT, Ltd	8e255bc7-a120-460a-a32d-43931f8115de	2026-05-21	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	0b92a940-0dd4-4266-bd47-88c27def62c0	2026-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
WHITENING SUNSCREENANTI WRINKLE	WHITENING SUNSCREENANTI WRINKLE	Shantou Oushiya Biotechnology Co.,Ltd	524384e9-b3f8-4c13-e063-6394a90a8973	2026-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	5ae78a86-ccca-4714-b77e-7bc885b674b5	2026-05-20	Warnings, Adverse reactions	Exact identifier rxcui: 314231 unii: AGG2FN16EV
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc.	fded7dfb-ffb9-4fb0-9511-273e0e126969	2026-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
Freaks of Nature Peak Performance Broad Spectrum SPF 50	FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50	THE FREAKS OF NATURE, INC.	5247187d-a14c-6468-e063-6394a90ace3e	2026-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	522d0f7f-f20b-bc17-e063-6294a90a3648	2026-05-19	Warnings, Adverse reactions	Exact identifier rxcui: 314231 unii: AGG2FN16EV
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc.	23cc5ff4-f842-4e3e-ac5c-23dbaf7d3914	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	SICOS ET CIE	c688f8e6-2cd2-40db-b03f-90fd74c2d89c	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	7df9dbd2-7db9-4961-819d-e93d14a065c3	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	20efd5fa-3077-4fd4-82d0-ddca946e4528	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	OCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	51c353cb-94c4-e110-e063-6394a90a497e	2026-05-14	Warnings	Exact identifier unii: 15FIX9V2JP
C07 STRONG LIGAMENTS AND JOINTS	ARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALE	Apex Energetics Inc.	bccf8c83-a6cd-e58c-e053-2a95a90a43d7	2026-05-13	Warnings	Exact identifier unii: PQ6CK8PD0R
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	aa8aed58-691b-472e-8e98-53d0d3f56686	2026-05-12	Warnings, Adverse reactions	Exact identifier application number: ANDA078155 rxcui: 314231 unii: AGG2FN16EV
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	7463b093-c2ee-49c3-a08a-e758de66422a	2026-05-12	Warnings, Adverse reactions	Exact identifier application number: ANDA078155 rxcui: 198211 unii: AGG2FN16EV
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36	2026-05-12	Warnings, Adverse reactions	Exact identifier application number: ANDA078155 rxcui: 200345 unii: AGG2FN16EV
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	aedde765-931f-430e-9fc3-d87bde2b78cd	2026-05-12	Warnings	Exact identifier unii: 15FIX9V2JP
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	417305d7-d32e-4bc9-8f77-0a42b6bdecf5	2026-05-12	Warnings	Exact identifier unii: 15FIX9V2JP
SIMVASTATIN	SIMVASTATIN	QPharma, Inc	f71fc0ac-223e-18c1-e053-6394a90a45ca	2026-05-11	Warnings, Adverse reactions	Exact identifier rxcui: 312961 unii: AGG2FN16EV
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	CVS Pharmacy	db6f518d-3a0e-43f8-8d19-7382d9b7ff1c	2026-05-11	Warnings	Exact identifier unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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