simvastatin

Product NDC: 42254-060
11-digit product format: 422540060
Labeler code: 42254
Product ID: 42254-060_330e35ed-fd6b-4123-864a-a5aa339c24d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
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: E
Listing certified through: 2017-12-31
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	42254-060		I	Inactivated by FDA	2026-08-11
excluded package	package	42254-060	42254-060-30	I	Inactivated by FDA	2026-08-11
excluded package	package	42254-060	42254-060-90	I	Inactivated by FDA	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 2 · 66 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	42254-060-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-060-30	`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	42254-060-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-060-30	`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	42254-060-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-060-30	`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	42254-060-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-060-30	`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	42254-060-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-060-30	`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	42254-060-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-060-30	`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	42254-060-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-060-30	`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	42254-060-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-060-30	`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	42254-060-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-060-30	`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	42254-060-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-060-30	`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	42254-060-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-060-30	`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	42254-060-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-060-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-060-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-060-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-060-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-060-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-060-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-060-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-060-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-060-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-060-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-060-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-060-90	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-060-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-060-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-060-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-060-90	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-060-30	`e2bbac7714bc…`	`27bdfed8d636…`

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	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 · 205 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
2026-02-19 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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078155-005	AB	1	`5bbf6a4d5a75…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-060-30	2019-09-24	C162847	48780-1	9350213a-3c0b-c013-e053-90daa90a1393	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 Initial U.S. Approval: 1991
42254-060-90	2019-09-24	C162847	48780-1	9350213a-3c0b-c013-e053-90daa90a1393	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 Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-060-30	simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30		1
42254-060-90	simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-060-30	EA - Each	42254-060	9c96fced-4d06-4c7f-a203-297960bcd021	1	2012-07-24
42254-060-90	EA - Each	42254-060	5bc51fcb-7f65-4be7-b73d-6e635ff4a5d2	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 [REBEL DISTRIBUTORS CORP]	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
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	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
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-060	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20120420_330e35ed-fd6b-4123-864a-a5aa339c24d6.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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	aa8aed58-691b-472e-8e98-53d0d3f56686	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	7463b093-c2ee-49c3-a08a-e758de66422a	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	c03ab80c-a3ae-4634-a76b-f53740db76f5	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	db0f4c5a-e8e4-3ab1-e053-2995a90a1f9a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f32d512f-86fa-b70f-e053-2a95a90afd01	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	QPharma, Inc.	c80b823c-b30f-0a9d-e053-2995a90a31e9	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Accord Healthcare, Inc.	871251c0-36a1-4a32-9eab-ff6c1e925ca9	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	56456210-2db5-4f0d-e054-00144ff8d46c	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	356ed6a6-e467-4791-87ff-2ae7779fc1b0	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	ce3ac5e8-bdef-d195-e0a0-e1a982008efe	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	79ca09cd-2396-4e50-b159-1f9567115067	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c236ce-69c2-06ef-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c28733-eb99-10f6-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8ed46bb1-9f84-4418-e053-2a95a90abd4b	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8e986df7-3020-6755-e053-2995a90aca37	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	A-S Medication Solutions	aaeebbc3-2608-41b5-8420-5a2a80316d39	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Proficient Rx LP	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	b5bebcd0-84e6-410d-af96-63834d262bad	2021-04-27	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
314231	simvastatin 10 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
198211	simvastatin 40 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
200345	simvastatin 80 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
314231	simvastatin 10 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-060-30	42254006030	30 in 1 BOTTLE	Historical
42254-060-90	42254006090	90 in 1 BOTTLE	Historical