simvastatin

Product NDC: 16729-005
11-digit product format: 167290005
Labeler code: 16729
Product ID: 16729-005_43910ff2-6a21-bf9e-e063-6294a90a3f5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Accord Healthcare, Inc.
Application: ANDA078155
Marketing category: ANDA
Marketing start: 2008-02-26
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
Ingredient	Strength
SIMVASTATIN	20 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	AGG2FN16EV
Rxcui	198211, 200345, 312961, 312962, 314231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6	Product name	1	20160615
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508

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 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 [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 [UNIT DOSE SERVICES]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	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 [RXCHANGE CO.]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	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 [AIDAREX PHARMACEUTICALS LLC]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	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 [BLENHEIM PHARMACAL, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	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 [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	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 [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	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 [REBEL DISTRIBUTORS CORP]	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 [STATE OF FLORIDA DOH CENTRAL PHARMACY]	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 [RXCHANGE CO.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	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
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 [STATE OF FLORIDA DOH CENTRAL PHARMACY]	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
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AGG2FN16EV	SIMVASTATIN	79902-63-9	SIMVASTATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312961	simvastatin 20 MG Oral Tablet	PSN	79ca09cd-2396-4e50-b159-1f9567115067	1012
312961	simvastatin 20 MG Oral Tablet	SCD	79ca09cd-2396-4e50-b159-1f9567115067	1012
314231	simvastatin 10 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312961	simvastatin 20 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
198211	simvastatin 40 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312962	simvastatin 5 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
200345	simvastatin 80 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
314231	simvastatin 10 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312961	simvastatin 20 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
198211	simvastatin 40 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312962	simvastatin 5 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
200345	simvastatin 80 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
314231	simvastatin 10 MG Oral Tablet	PSN	f2a20844-9918-40f6-be69-6dea54b877a7	13
312961	simvastatin 20 MG Oral Tablet	PSN	f2a20844-9918-40f6-be69-6dea54b877a7	13
198211	simvastatin 40 MG Oral Tablet	PSN	f2a20844-9918-40f6-be69-6dea54b877a7	13
314231	simvastatin 10 MG Oral Tablet	SCD	f2a20844-9918-40f6-be69-6dea54b877a7	13
312961	simvastatin 20 MG Oral Tablet	SCD	f2a20844-9918-40f6-be69-6dea54b877a7	13
198211	simvastatin 40 MG Oral Tablet	SCD	f2a20844-9918-40f6-be69-6dea54b877a7	13
312961	simvastatin 20 MG Oral Tablet	PSN	e3a08f36-d80a-40e2-8572-d9b991b60c0d	11
198211	simvastatin 40 MG Oral Tablet	PSN	e3a08f36-d80a-40e2-8572-d9b991b60c0d	11
312961	simvastatin 20 MG Oral Tablet	SCD	e3a08f36-d80a-40e2-8572-d9b991b60c0d	11
198211	simvastatin 40 MG Oral Tablet	SCD	e3a08f36-d80a-40e2-8572-d9b991b60c0d	11
314231	simvastatin 10 MG Oral Tablet	PSN	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
312961	simvastatin 20 MG Oral Tablet	PSN	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
198211	simvastatin 40 MG Oral Tablet	PSN	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
314231	simvastatin 10 MG Oral Tablet	SCD	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
312961	simvastatin 20 MG Oral Tablet	SCD	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
198211	simvastatin 40 MG Oral Tablet	SCD	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
312961	simvastatin 20 MG Oral Tablet	PSN	aaeebbc3-2608-41b5-8420-5a2a80316d39	5
312961	simvastatin 20 MG Oral Tablet	PSN	4182c956-eb33-1d4b-e054-00144ff88e88	5
312961	simvastatin 20 MG Oral Tablet	PSN	db08460d-5184-42fa-8435-76eefa3569f5	5
312961	simvastatin 20 MG Oral Tablet	SCD	aaeebbc3-2608-41b5-8420-5a2a80316d39	5
312961	simvastatin 20 MG Oral Tablet	SCD	db08460d-5184-42fa-8435-76eefa3569f5	5
312961	simvastatin 20 MG Oral Tablet	SCD	4182c956-eb33-1d4b-e054-00144ff88e88	5
312961	simvastatin 20 MG Oral Tablet	PSN	c80b823c-b30f-0a9d-e053-2995a90a31e9	4
312961	simvastatin 20 MG Oral Tablet	PSN	8ed46bb1-9f84-4418-e053-2a95a90abd4b	4
312961	simvastatin 20 MG Oral Tablet	PSN	49233a3c-c2b0-03ca-e054-00144ff8d46c	4
312961	simvastatin 20 MG Oral Tablet	PSN	54c28733-eb99-10f6-e054-00144ff88e88	4
312961	simvastatin 20 MG Oral Tablet	SCD	49233a3c-c2b0-03ca-e054-00144ff8d46c	4
312961	simvastatin 20 MG Oral Tablet	SCD	8ed46bb1-9f84-4418-e053-2a95a90abd4b	4
312961	simvastatin 20 MG Oral Tablet	SCD	54c28733-eb99-10f6-e054-00144ff88e88	4
312961	simvastatin 20 MG Oral Tablet	SCD	c80b823c-b30f-0a9d-e053-2995a90a31e9	4
312961	simvastatin 20 MG Oral Tablet	PSN	0be2e371-1f05-48d7-8f2e-f2024f3305f3	3
312961	simvastatin 20 MG Oral Tablet	SCD	0be2e371-1f05-48d7-8f2e-f2024f3305f3	3
312961	simvastatin 20 MG Oral Tablet	PSN	597c10d1-76fb-1408-e053-2991aa0a78d2	2
312961	simvastatin 20 MG Oral Tablet	PSN	6fcd7ba3-02cd-41e9-85d5-494961155d3e	2
198211	simvastatin 40 MG Oral Tablet	PSN	597c10d1-76fb-1408-e053-2991aa0a78d2	2
198211	simvastatin 40 MG Oral Tablet	PSN	6fcd7ba3-02cd-41e9-85d5-494961155d3e	2
312961	simvastatin 20 MG Oral Tablet	SCD	597c10d1-76fb-1408-e053-2991aa0a78d2	2
312961	simvastatin 20 MG Oral Tablet	SCD	6fcd7ba3-02cd-41e9-85d5-494961155d3e	2
198211	simvastatin 40 MG Oral Tablet	SCD	597c10d1-76fb-1408-e053-2991aa0a78d2	2
198211	simvastatin 40 MG Oral Tablet	SCD	6fcd7ba3-02cd-41e9-85d5-494961155d3e	2
314231	simvastatin 10 MG Oral Tablet	PSN	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
314231	simvastatin 10 MG Oral Tablet	PSN	0f878e82-7ce1-450b-abb0-2090c22b389b	1
314231	simvastatin 10 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	PSN	8d63e5de-d89c-4d2a-970d-7d17f993b7fe	1
312961	simvastatin 20 MG Oral Tablet	PSN	0f878e82-7ce1-450b-abb0-2090c22b389b	1
312961	simvastatin 20 MG Oral Tablet	PSN	e6611157-4a8f-4de3-a858-b4f518cad7c4	1
312961	simvastatin 20 MG Oral Tablet	PSN	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
312961	simvastatin 20 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	PSN	09f1f736-3737-4e2d-96d2-fe5abdc72cac	1
198211	simvastatin 40 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
198211	simvastatin 40 MG Oral Tablet	PSN	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
198211	simvastatin 40 MG Oral Tablet	PSN	0f878e82-7ce1-450b-abb0-2090c22b389b	1
200345	simvastatin 80 MG Oral Tablet	PSN	8d63e5de-d89c-4d2a-970d-7d17f993b7fe	1
200345	simvastatin 80 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
314231	simvastatin 10 MG Oral Tablet	SCD	0f878e82-7ce1-450b-abb0-2090c22b389b	1
314231	simvastatin 10 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
314231	simvastatin 10 MG Oral Tablet	SCD	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
312961	simvastatin 20 MG Oral Tablet	SCD	8d63e5de-d89c-4d2a-970d-7d17f993b7fe	1
312961	simvastatin 20 MG Oral Tablet	SCD	09f1f736-3737-4e2d-96d2-fe5abdc72cac	1
312961	simvastatin 20 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	SCD	0f878e82-7ce1-450b-abb0-2090c22b389b	1
312961	simvastatin 20 MG Oral Tablet	SCD	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
312961	simvastatin 20 MG Oral Tablet	SCD	e6611157-4a8f-4de3-a858-b4f518cad7c4	1
198211	simvastatin 40 MG Oral Tablet	SCD	0f878e82-7ce1-450b-abb0-2090c22b389b	1
198211	simvastatin 40 MG Oral Tablet	SCD	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
198211	simvastatin 40 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
200345	simvastatin 80 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
200345	simvastatin 80 MG Oral Tablet	SCD	8d63e5de-d89c-4d2a-970d-7d17f993b7fe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-005-10	16729000510	30 TABLET, FILM COATED in 1 BOTTLE (16729-005-10)	2008-02-26	0000-00-00	No	No	Current
16729-005-12	16729000512	60 in 1 BOTTLE					Historical
16729-005-15	16729000515	90 TABLET, FILM COATED in 1 BOTTLE (16729-005-15)	2008-02-26	0000-00-00	No	No	Current
16729-005-17	16729000517	1000 TABLET, FILM COATED in 1 BOTTLE (16729-005-17)	2008-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
simvastatin	QPharma, Inc. \| Accord Healthcare, Inc. \| Northwind Health Company, LLC	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	4
simvastatin	Accord Healthcare, Inc. \| Intas Pharmaceuticals Limited.	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	22
simvastatin	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	1012
simvastatin	NuCare Pharmaceuticals,Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	4
simvastatin	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	4
simvastatin	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	13
simvastatin	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	5
SIMVASTATIN	Direct Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	5
simvastatin	Proficient Rx LP	2022-05-01	HUMAN PRESCRIPTION DRUG LABEL	8
simvastatin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	5
simvastatin	NuCare Pharmaceuticals, Inc.	2021-03-31	HUMAN PRESCRIPTION DRUG LABEL	4
simvastatin	Contract Pharmacy Services-PA \| Coupler Enterprises	2018-12-29	HUMAN PRESCRIPTION DRUG LABEL	2
simvastatin	Aphena Pharma Solutions - Tennessee, LLC	2018-04-26	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	Unit Dose Services	2017-07-01	HUMAN PRESCRIPTION DRUG LABEL	3
simvastatin	Blenheim Pharmacal, Inc.	2015-11-25	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	RxChange Co.	2014-11-20	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	State of Florida DOH Central Pharmacy	2014-09-30	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	ReadyMeds	2014-07-01	HUMAN PRESCRIPTION DRUG LABEL	11
simvastatin	Aidarex Pharmaceuticals LLC	2014-01-31	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	1
Simvastatin	H.J. Harkins Company, Inc. \| Intas Pharmaceuticals Ltd.	2011-12-14	HUMAN PRESCRIPTION DRUG LABEL	2

simvastatin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#