Simvastatin

Product NDC: 0093-7155
11-digit product format: 000937155
Labeler code: 0093
Product ID: 0093-7155_68c57a69-a821-44fb-a778-a91e2c1c5f5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA076052
Marketing category: ANDA
Marketing start: 2006-06-27
Marketing end: 2020-05-31
Substance: SIMVASTATIN
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0093-7155		D	Discontinued by firm	2026-08-11
excluded package	package	0093-7155	0093-7155-10	D	Discontinued by firm	2026-08-11
excluded package	package	0093-7155	0093-7155-31	D	Discontinued by firm	2026-08-11
excluded package	package	0093-7155	0093-7155-98	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-7155-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-7155-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-7155-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-7155-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-7155-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-7155-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-7155-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-7155-98	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-7155-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-7155-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-7155-98	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-7155-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-7155-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-7155-98	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-7155-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-7155-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-7155-98	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-7155-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-7155-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-7155-98	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-7155-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-7155-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-7155-98	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-7155-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-7155-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-7155-98	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-7155-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-7155-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-7155-98	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-7155-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-7155-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-7155-98	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-7155-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-7155-31	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-7155-98	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-7155-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A076052-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23
A076052-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23
A076052-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23
A076052-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23
A076052-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20

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 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076052-001	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076052-002	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076052-003	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076052-004	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076052-005	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076052-001	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076052-002	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076052-003	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076052-004	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076052-005	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076052-001	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076052-002	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076052-003	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076052-004	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076052-005	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076052-001	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076052-002	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076052-003	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076052-004	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076052-005	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076052-001	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076052-002	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076052-003	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076052-004	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076052-005	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076052-001	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076052-002	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076052-003	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076052-004	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076052-005	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076052-001	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076052-002	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076052-003	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076052-004	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076052-005	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076052-001	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076052-002	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076052-003	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076052-004	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076052-005	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20	`5bbf6a4d5a75…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7155-10	EA - Each	0093-7155	cb88c5d5-3dff-4739-a791-3444c5c3fd73	1	2012-07-24
0093-7155-19	EA - Each	0093-7155	cef03fb2-0b7b-4122-a31f-4dad3ec956a7	1	2012-07-24
0093-7155-31	EA - Each	0093-7155	a22e4778-beac-470b-81ed-63826b848158	1	2017-07-07
0093-7155-56	EA - Each	0093-7155	534e8129-ff4e-489a-b2db-e5af67629641	1	2012-07-24
0093-7155-93	EA - Each	0093-7155	25f9b8f5-4779-4e9c-9592-49a685f2c088	1	2012-07-24
0093-7155-98	EA - Each	0093-7155	b5dbd687-146a-49e2-9d25-34a0188aaf90	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 [MYLAN INSTITUTIONAL INC.]	2
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Simvastatin	Mylan Institutional Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	6
Simvastatin	Teva Pharmaceuticals USA, Inc.	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	8
Simvastatin	Preferred Pharmaceuticals, Inc.	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	1
Simvastatin	QPharma Inc \| Teva Pharmaceuticals USA, Inc. \| Denton Pharma, Inc.	2019-01-09	HUMAN PRESCRIPTION DRUG LABEL	2