Lescol

Product NDC: 0078-0354
11-digit product format: 000780354
Labeler code: 0078
Product ID: 0078-0354_04f77269-0504-4ffb-88cf-5834cfc6b173
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluvastatin sodium
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA021192
Marketing category: NDA
Marketing start: 2000-10-06
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: No
Listing certified through: 2023-12-31
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	0078-0354		D	Discontinued by firm	2026-08-11
excluded package	package	0078-0354	0078-0354-05	D	Discontinued by firm	2026-08-11
excluded package	package	0078-0354	0078-0354-15	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 · 16 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	0078-0354-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0078-0354-05	`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	0078-0354-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0078-0354-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0078-0354-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0078-0354-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0078-0354-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0078-0354-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0078-0354-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0078-0354-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0078-0354-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0078-0354-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0078-0354-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0078-0354-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0354-05	EA - Each	0078-0354	8016e7bf-ec59-4910-bd4b-55bc1dd7dbaa	1	2012-07-24
0078-0354-15	EA - Each	0078-0354	d7f38635-684e-4226-821b-ea904a2a7b82	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUVASTATIN SODIUM	ACTIVE INGREDIENT	PYF7O1FV7F	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
FLUVASTATIN	ACTIVE MOIETY	4L066368AS	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	10
FLUVASTATIN SODIUM	ACTIVE INGREDIENT	PYF7O1FV7F	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FLUVASTATIN	ACTIVE MOIETY	4L066368AS	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FLUVASTATIN SODIUM	ACTIVE INGREDIENT	PYF7O1FV7F	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
FLUVASTATIN	ACTIVE MOIETY	4L066368AS	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0354	LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	24	Legacy NDC	20231209_8a1823e7-26fb-4858-bac7-9e152e5ea16a.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

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	cd12fae6-f277-4679-a7a8-b98719fe6fa9	2
687048	Lescol XL 80 MG 24HR Extended Release Oral Tablet	PSN	cd12fae6-f277-4679-a7a8-b98719fe6fa9	2
687048	24 HR fluvastatin 80 MG Extended Release Oral Tablet [Lescol]	SBD	cd12fae6-f277-4679-a7a8-b98719fe6fa9	2
360507	24 HR fluvastatin 80 MG Extended Release Oral Tablet	SCD	cd12fae6-f277-4679-a7a8-b98719fe6fa9	2
687048	24 HR Lescol XL (as fluvastatin sodium) 80 MG Extended Release Oral Tablet	SY	cd12fae6-f277-4679-a7a8-b98719fe6fa9	2
360507	fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral Tablet	SY	cd12fae6-f277-4679-a7a8-b98719fe6fa9	2
360507	fluvastatin 80 MG 24 HR Extended Release Oral Tablet	SY	cd12fae6-f277-4679-a7a8-b98719fe6fa9	2
687048	Lescol XL 80 MG 24 HR Extended Release Oral Tablet	SY	cd12fae6-f277-4679-a7a8-b98719fe6fa9	2
360507	fluvastatin sodium 80 MG 24HR Extended Release Oral Tablet	PSN	0d466214-78a8-44cd-923c-c286a0f74f66	1
687048	Lescol XL 80 MG 24HR Extended Release Oral Tablet	PSN	0d466214-78a8-44cd-923c-c286a0f74f66	1
687048	24 HR fluvastatin 80 MG Extended Release Oral Tablet [Lescol]	SBD	0d466214-78a8-44cd-923c-c286a0f74f66	1
360507	24 HR fluvastatin 80 MG Extended Release Oral Tablet	SCD	0d466214-78a8-44cd-923c-c286a0f74f66	1
687048	24 HR Lescol XL (as fluvastatin sodium) 80 MG Extended Release Oral Tablet	SY	0d466214-78a8-44cd-923c-c286a0f74f66	1
360507	fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral Tablet	SY	0d466214-78a8-44cd-923c-c286a0f74f66	1
360507	fluvastatin 80 MG 24 HR Extended Release Oral Tablet	SY	0d466214-78a8-44cd-923c-c286a0f74f66	1
687048	Lescol XL 80 MG 24 HR Extended Release Oral Tablet	SY	0d466214-78a8-44cd-923c-c286a0f74f66	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0354-05	00078035405	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-05)	2000-10-06	2021-02-28	No	No	Current
0078-0354-15	00078035415	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-15)	2000-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lescol XL	Novartis Pharmaceuticals Corporation	2023-11-07	HUMAN PRESCRIPTION DRUG LABEL	24
Lescol XL	Carilion Materials Management	2012-10-31	HUMAN PRESCRIPTION DRUG LABEL	2
LESCOL XL - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-03-23	HUMAN PRESCRIPTION DRUG LABEL	1