FLUVASTATIN SODIUM

Product NDC: 0781-5370
11-digit product format: 007815370
Labeler code: 0781
Product ID: 0781-5370_c184692f-4afa-47b9-80d3-481fde50a4fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluvastatin sodium
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sandoz Inc
Application: NDA021192
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-10-16
Marketing end: 0000-00-00
Substance: FLUVASTATIN SODIUM
Active strength: 80 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
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	0781-5370		D	Discontinued by firm	2026-08-11
excluded package	package	0781-5370	0781-5370-01	D	Discontinued by firm	2026-08-11
excluded package	package	0781-5370	0781-5370-31	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 · 45 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5370-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5370-31	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5370-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5370-31	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5370-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5370-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5370-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5370-31	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5370-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5370-31	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5370-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5370-31	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5370-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5370-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5370-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5370-31	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5370-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5370-31	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5370-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5370-31	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-5370-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-5370-31	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-5370-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-5370-31	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0781-5370-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0781-5370-31	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0781-5370-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0781-5370-31	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
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	0781-5370-31	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	0781-5370-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021192-001	LESCOL XL	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021192-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N021192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021192-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021192-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021192-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021192-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021192-001	6242003	2020-04-13		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021192-001	6242003	2020-04-13		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021192-001	6242003	2020-04-13		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021192-001	6242003	2020-04-13		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021192-001	6242003	2020-04-13		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021192-001	6242003	2020-04-13		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0781-5370-01	2021-08-05	These highlights do not include all the information needed to use Fluvastatin Sodium Extended-Release Tablets, USP safely and effectively. See full prescribing information for Fluvastatin Sodium Extended-Release Tablets, USP Fluvastatin Sodium Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1993/ 2000
0781-5370-31	2021-08-05	These highlights do not include all the information needed to use Fluvastatin Sodium Extended-Release Tablets, USP safely and effectively. See full prescribing information for Fluvastatin Sodium Extended-Release Tablets, USP Fluvastatin Sodium Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1993/ 2000
0781-5370-01	2020-01-31	These highlights do not include all the information needed to use Fluvastatin Sodium Extended-Release Tablets, USP safely and effectively. See full prescribing information for Fluvastatin Sodium Extended-Release Tablets, USP Fluvastatin Sodium Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1993/ 2000
0781-5370-31	2020-01-31	These highlights do not include all the information needed to use Fluvastatin Sodium Extended-Release Tablets, USP safely and effectively. See full prescribing information for Fluvastatin Sodium Extended-Release Tablets, USP Fluvastatin Sodium Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1993/ 2000

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5370-01	EA - Each	0781-5370	2c4d6495-6ec1-4b21-87e5-de8f95d00419	1	2015-11-12
0781-5370-31	EA - Each	0781-5370	95e6203f-4dd2-45b7-ba20-712355f17793	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUVASTATIN SODIUM	ACTIVE INGREDIENT	PYF7O1FV7F	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
FLUVASTATIN	ACTIVE MOIETY	4L066368AS	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUVASTATIN SODIUM ER (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	5

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUVASTATIN SODIUM ER	FLUVASTATIN SODIUM	Sandoz Inc	5ab4296c-87c2-4c64-b218-d620eef51310	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021192 application number: NDA021192
Lescol XL	FLUVASTATIN SODIUM	Sandoz Inc	726ea2db-f1b0-4b73-a515-02157db88a42	2023-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021192 application number: NDA021192