Lescol

Product NDC: 66758-211
11-digit product format: 667580211
Labeler code: 66758
Product ID: 66758-211_726ea2db-f1b0-4b73-a515-02157db88a42
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluvastatin sodium
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sandoz Inc
Application: NDA021192
Marketing category: NDA
Marketing start: 2000-10-06
Substance: FLUVASTATIN SODIUM
Active strength: 80 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	66758-211	66758-211-01	D	Discontinued by firm		2026-10-16

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 · 11 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 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
2026-10-15 13:18:30	2026-09	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021192-001	AB	1	`a50c72e98297…`

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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Lescol
Brand name suffix: XL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUVASTATIN SODIUM	80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PYF7O1FV7F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
360507	Internal RxNorm lookup
687048	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
726ea2db-f1b0-4b73-a515-02157db88a42	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
22ca7ed4-2e69-d74c-9eff-803d6d02a7be	Product name	4	20211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66758-211-01	LescolXL	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1
66758-211-31	LescolXL	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66758-211-31	EA - Each	66758-211	b86e6f02-b04f-4539-b688-76ff9d48573e	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66758-211	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]	1	Current NDC, 2 package rows	20240805_726ea2db-f1b0-4b73-a515-02157db88a42.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 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 ndc (product): 66758-211

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PYF7O1FV7F	FLUVASTATIN SODIUM	93957-55-2	FLUVASTATIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
360507	fluvastatin sodium 80 MG 24HR Extended Release Oral Tablet	PSN	726ea2db-f1b0-4b73-a515-02157db88a42	1
687048	Lescol XL 80 MG 24HR Extended Release Oral Tablet	PSN	726ea2db-f1b0-4b73-a515-02157db88a42	1
687048	24 HR fluvastatin 80 MG Extended Release Oral Tablet [Lescol]	SBD	726ea2db-f1b0-4b73-a515-02157db88a42	1
360507	24 HR fluvastatin 80 MG Extended Release Oral Tablet	SCD	726ea2db-f1b0-4b73-a515-02157db88a42	1
687048	24 HR Lescol XL (as fluvastatin sodium) 80 MG Extended Release Oral Tablet	SY	726ea2db-f1b0-4b73-a515-02157db88a42	1
360507	fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral Tablet	SY	726ea2db-f1b0-4b73-a515-02157db88a42	1
360507	fluvastatin 80 MG 24 HR Extended Release Oral Tablet	SY	726ea2db-f1b0-4b73-a515-02157db88a42	1
687048	Lescol XL 80 MG 24 HR Extended Release Oral Tablet	SY	726ea2db-f1b0-4b73-a515-02157db88a42	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
66758-211-01	66758021101	100 in 1 BOTTLE				Historical
66758-211-31	66758021131	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31)	2024-08-02	No	No	Current