Simvastatin

Product NDC: 54458-933
11-digit product format: 544580933
Labeler code: 54458
Product ID: 54458-933_3c229a59-320d-4708-bb6b-5a5ff06fb409
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: International Laboratories, LLC
Application: ANDA076052
Marketing category: ANDA
Marketing start: 2010-11-27
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: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54458-933		I	Inactivated by FDA	2026-08-17
excluded package	package	54458-933	54458-933-10	I	Inactivated by FDA	2026-08-17
excluded package	package	54458-933	54458-933-16	I	Inactivated by FDA	2026-08-17

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54458-933-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54458-933-16	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54458-933-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54458-933-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54458-933-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54458-933-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54458-933-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54458-933-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54458-933-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54458-933-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54458-933-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54458-933-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54458-933-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54458-933-16	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54458-933-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54458-933-16	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54458-933-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54458-933-16	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54458-933-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54458-933-16	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54458-933-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54458-933-16	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54458-933-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54458-933-16	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54458-933-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54458-933-16	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54458-933-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54458-933-16	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54458-933-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54458-933-16	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54458-933-10	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54458-933-16	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54458-933-10	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54458-933-16	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54458-933-10	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54458-933-16	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54458-933-10	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54458-933-16	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54458-933-16	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54458-933-10	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076052-001	SIMVASTATIN	5MG	TABLET / ORAL	2006-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076052-002	SIMVASTATIN	10MG	TABLET / ORAL	2006-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076052-003	SIMVASTATIN	20MG	TABLET / ORAL	2006-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076052-004	SIMVASTATIN	40MG	TABLET / ORAL	2006-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076052-005	SIMVASTATIN	80MG	TABLET / ORAL	2006-12-20	`caaa826d4ba7…`
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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6	Product name	1	20160615
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54458-933-10	2021-01-29	C162847	48780-1	ba0f9c33-2ab5-a910-e053-dadaa90a0b85	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, for oral use Initial U.S. Approval: 1991
54458-933-16	2021-01-29	C162847	48780-1	ba0f9c33-2ab5-a910-e053-dadaa90a0b85	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, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54458-933-10	Simvastatin	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		38
54458-933-16	Simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30		38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54458-933-10	EA - Each	54458-933	611ce771-eec0-491b-a696-09076ffc9b53	1	2012-07-24
54458-933-16	EA - Each	54458-933	54534967-e60d-49c4-b793-1054de1ce276	1	2017-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54458-933	SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, LLC]	38	Legacy NDC, 2 package rows	20191219_1c5178c9-270f-4a5b-a52b-68a56972f035.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
314231	simvastatin 10 MG Oral Tablet	PSN	1c5178c9-270f-4a5b-a52b-68a56972f035	38
312961	simvastatin 20 MG Oral Tablet	PSN	1c5178c9-270f-4a5b-a52b-68a56972f035	38
198211	simvastatin 40 MG Oral Tablet	PSN	1c5178c9-270f-4a5b-a52b-68a56972f035	38
314231	simvastatin 10 MG Oral Tablet	SCD	1c5178c9-270f-4a5b-a52b-68a56972f035	38
312961	simvastatin 20 MG Oral Tablet	SCD	1c5178c9-270f-4a5b-a52b-68a56972f035	38
198211	simvastatin 40 MG Oral Tablet	SCD	1c5178c9-270f-4a5b-a52b-68a56972f035	38

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
54458-933-10	54458093310	30 in 1 BLISTER PACK	Historical
54458-933-16	54458093316	30 in 1 BOTTLE	Historical