simvastatin

Product NDC: 68071-1990
Requested package NDC: 68071-1990-3
11-digit product format: 680711990
Labeler code: 68071
Product ID: 68071-1990_bedd3c21-288a-da48-e053-2995a90a75fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA078155
Marketing category: ANDA
Marketing start: 2008-02-26
Marketing end: 0000-00-00
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-1990	68071-1990-3	I	Inactivated by FDA		2026-10-12

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A078155-001	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26
A078155-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26
A078155-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26
A078155-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26
A078155-005	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078155-001	AB
A078155-002	AB
A078155-003	AB
A078155-004	AB
A078155-005	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	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`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	A078155-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078155-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078155-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078155-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-1990-3	2023-01-30	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-5	2023-01-30	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-6	2023-01-30	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-9	2023-01-30	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-3	2021-03-31	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-5	2021-03-31	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-6	2021-03-31	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-9	2021-03-31	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-3	2021-01-29	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-5	2021-01-29	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-6	2021-01-29	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
68071-1990-9	2021-01-29	These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-1990-3	simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
68071-1990-5	simvastatin	45 in 1 BOTTLE	TABLET, FILM COATED	45	4
68071-1990-6	simvastatin	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
68071-1990-9	simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1990	SIMVASTATIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]	4	Legacy NDC, 4 package rows	20210401_49233a3c-c2b0-03ca-e054-00144ff8d46c.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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	121b0e00-abb7-4e07-a7b2-311be89fabb7	2019-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155

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	49233a3c-c2b0-03ca-e054-00144ff8d46c	4
312961	simvastatin 20 MG Oral Tablet	SCD	49233a3c-c2b0-03ca-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1990-3	68071199003	30 TABLET, FILM COATED in 1 BOTTLE (68071-1990-3)	2017-02-22	0000-00-00	No	No	Current