Simvastatin

Product NDC: 16714-683
11-digit product format: 167140683
Labeler code: 16714
Product ID: 16714-683_6c353eba-27f3-43cc-b954-ec659881872f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA077691
Marketing category: ANDA
Marketing start: 2006-12-20
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077691-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20
A077691-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20
A077691-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20
A077691-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20
A077691-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A077691-001	AB
A077691-002	AB
A077691-003	AB
A077691-004	AB
A077691-005	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077691-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077691-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077691-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077691-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Simvastatin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SIMVASTATIN	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
AGG2FN16EV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198211	Internal RxNorm lookup
200345	Internal RxNorm lookup
312961	Internal RxNorm lookup
312962	Internal RxNorm lookup
314231	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0376351b-f1a0-43e5-a0b4-533072c49f39	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
16714-683-01	Simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	24
16714-683-02	Simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	24
16714-683-03	Simvastatin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-683-01	EA - Each	16714-683	f3d4a23e-5296-45d5-a136-3b86ee9b179f	1	2012-07-24
16714-683-02	EA - Each	16714-683	3df10d22-3540-4526-bce9-6b86a4fdbbdf	1	2012-07-24
16714-683-03	EA - Each	16714-683	bf85693f-a69d-452b-bcc4-babbd675f0f8	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 [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	9
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	3
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-683	SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]	24	Current NDC, Legacy NDC, 3 package rows	20240425_0376351b-f1a0-43e5-a0b4-533072c49f39.zip

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	A-S Medication Solutions	7fc4df06-48cb-481a-b7b2-d951def683ea	2023-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	d09f88b5-b95f-4315-9b75-c09ce3d94397	2023-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	Proficient Rx LP	b5b47d5b-f953-4e82-99ef-e4e10164095e	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691

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
314231	simvastatin 10 MG Oral Tablet	PSN	0376351b-f1a0-43e5-a0b4-533072c49f39	24
312961	simvastatin 20 MG Oral Tablet	PSN	0376351b-f1a0-43e5-a0b4-533072c49f39	24
198211	simvastatin 40 MG Oral Tablet	PSN	0376351b-f1a0-43e5-a0b4-533072c49f39	24
312962	simvastatin 5 MG Oral Tablet	PSN	0376351b-f1a0-43e5-a0b4-533072c49f39	24
200345	simvastatin 80 MG Oral Tablet	PSN	0376351b-f1a0-43e5-a0b4-533072c49f39	24
314231	simvastatin 10 MG Oral Tablet	SCD	0376351b-f1a0-43e5-a0b4-533072c49f39	24
312961	simvastatin 20 MG Oral Tablet	SCD	0376351b-f1a0-43e5-a0b4-533072c49f39	24
198211	simvastatin 40 MG Oral Tablet	SCD	0376351b-f1a0-43e5-a0b4-533072c49f39	24
312962	simvastatin 5 MG Oral Tablet	SCD	0376351b-f1a0-43e5-a0b4-533072c49f39	24
200345	simvastatin 80 MG Oral Tablet	SCD	0376351b-f1a0-43e5-a0b4-533072c49f39	24
312961	simvastatin 20 MG Oral Tablet	PSN	9133520e-1ffd-4ef1-bced-6b0c9a579f39	12
312961	simvastatin 20 MG Oral Tablet	SCD	9133520e-1ffd-4ef1-bced-6b0c9a579f39	12
312961	simvastatin 20 MG Oral Tablet	PSN	6de29f85-92e9-4a28-9bcc-6789f2f698de	5
312961	simvastatin 20 MG Oral Tablet	SCD	6de29f85-92e9-4a28-9bcc-6789f2f698de	5
312961	simvastatin 20 MG Oral Tablet	PSN	cf85b795-82fa-3389-e053-2995a90af2fd	3
312961	simvastatin 20 MG Oral Tablet	SCD	cf85b795-82fa-3389-e053-2995a90af2fd	3
312961	simvastatin 20 MG Oral Tablet	PSN	0a1fe17b-75d4-d361-e063-6394a90ae188	2
312961	simvastatin 20 MG Oral Tablet	SCD	0a1fe17b-75d4-d361-e063-6394a90ae188	2
312961	simvastatin 20 MG Oral Tablet	PSN	b9c315ff-cec9-8b75-e053-2995a90aa204	1
312961	simvastatin 20 MG Oral Tablet	PSN	cc8258c3-6265-4b26-a1bf-df6476cc962a	1
312961	simvastatin 20 MG Oral Tablet	SCD	b9c315ff-cec9-8b75-e053-2995a90aa204	1
312961	simvastatin 20 MG Oral Tablet	SCD	cc8258c3-6265-4b26-a1bf-df6476cc962a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-683-01	16714068301	30 TABLET, FILM COATED in 1 BOTTLE (16714-683-01)	2006-12-20	0000-00-00	No	No	Current
16714-683-02	16714068302	90 TABLET, FILM COATED in 1 BOTTLE (16714-683-02)	2006-12-20	0000-00-00	No	No	Current
16714-683-03	16714068303	1000 TABLET, FILM COATED in 1 BOTTLE (16714-683-03)	2006-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Simvastatin	A-S Medication Solutions	2025-04-25	Human Prescription Drug Label	5
Simvastatin	A-S Medication Solutions	2025-04-24	Human Prescription Drug Label	12
Simvastatin	NuCare Pharmaceuticals,Inc.	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	3
Simvastatin	NuCare Pharmaceuticals,Inc.	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	2
Simvastatin	McKesson Corporation dba SKY Packaging \| LegacyPharmaceuticalPackaging, LLC	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	16
Simvastatin	NorthStar Rx LLC \| Aurobindo Pharma Limited	2024-04-15	Human Prescription Drug Label	24
Simvastatin	NuCare Pharmaceuticals,Inc.	2021-01-25	HUMAN PRESCRIPTION DRUG LABEL	1
Simvastatin	NCS HealthCare of KY, Inc dba Vangard Labs	2015-05-19	HUMAN PRESCRIPTION DRUG LABEL	10
Simvastatin	Safecor Health, LLC	2014-04-03	HUMAN PRESCRIPTION DRUG LABEL	1
Simvastatin	MedVantx, Inc. \| Aurobindo Pharma Limited \| Blenheim Pharmacal, Inc.	2010-09-14	HUMAN PRESCRIPTION DRUG LABEL	1