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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66758-21166758-211-01DDiscontinued by firm2026-08-11

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021192-001LESCOL XLFLUVASTATIN SODIUMEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021192-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-0687673890dc5c…
2021-03-12 10:30 UTC2021-03N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-063f01610625f2…
2019-09-15 20:21 UTC2019-09N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-063f0d92c62455…
2023-05-13 08:27 UTC2023-05N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06053a50430f4f…
2023-01-26 05:58 UTC2023-01N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021192-001LESCOL XLEQ 80MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2000-10-06cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021192-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021192-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021192-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021192-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021192-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021192-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021192-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021192-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021192-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021192-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021192-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021192-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021192-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021192-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021192-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021192-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021192-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021192-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021192-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021192-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021192-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021192-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021192-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021192-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021192-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021192-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021192-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021192-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021192-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021192-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021192-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021192-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021192-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021192-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021192-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021192-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021192-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021192-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021192-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021192-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021192-00162420032020-04-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021192-0016242003*PED2020-10-13Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021192-00162420032020-04-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021192-0016242003*PED2020-10-13Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021192-00162420032020-04-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021192-0016242003*PED2020-10-13Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021192-00162420032020-04-133f01610625f2…
2019-12-14 00:12 UTC2019-12N021192-0016242003*PED2020-10-13Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021192-00162420032020-04-13b00525d2431f…
2019-09-15 20:21 UTC2019-09N021192-0016242003*PED2020-10-13Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021192-00162420032020-04-13ea99ee380514…
2019-07-19 19:46 UTC2019-07N021192-0016242003*PED2020-10-13Pediatric extensionea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVASTATIN SODIUM80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PYF7O1FV7FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
726ea2db-f1b0-4b73-a515-02157db88a42Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
22ca7ed4-2e69-d74c-9eff-803d6d02a7beProduct name420211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66758-211-01LescolXL100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
66758-211-31LescolXL30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-211-31EA - Each66758-211b86e6f02-b04f-4539-b688-76ff9d48573e12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-211LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]1Current NDC, 2 package rows20240805_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUVASTATIN SODIUM ERFLUVASTATIN SODIUMSandoz Inc5ab4296c-87c2-4c64-b218-d620eef513102024-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021192
application number: NDA021192
Lescol XLFLUVASTATIN SODIUMSandoz Inc726ea2db-f1b0-4b73-a515-02157db88a422023-12-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 021192
application number: NDA021192
ndc (product): 66758-211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360507fluvastatin sodium 80 MG 24HR Extended Release Oral TabletPSN726ea2db-f1b0-4b73-a515-02157db88a421
687048Lescol XL 80 MG 24HR Extended Release Oral TabletPSN726ea2db-f1b0-4b73-a515-02157db88a421
68704824 HR fluvastatin 80 MG Extended Release Oral Tablet [Lescol]SBD726ea2db-f1b0-4b73-a515-02157db88a421
36050724 HR fluvastatin 80 MG Extended Release Oral TabletSCD726ea2db-f1b0-4b73-a515-02157db88a421
68704824 HR Lescol XL (as fluvastatin sodium) 80 MG Extended Release Oral TabletSY726ea2db-f1b0-4b73-a515-02157db88a421
360507fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral TabletSY726ea2db-f1b0-4b73-a515-02157db88a421
360507fluvastatin 80 MG 24 HR Extended Release Oral TabletSY726ea2db-f1b0-4b73-a515-02157db88a421
687048Lescol XL 80 MG 24 HR Extended Release Oral TabletSY726ea2db-f1b0-4b73-a515-02157db88a421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
66758-211-0166758021101100 in 1 BOTTLEHistorical
66758-211-316675802113130 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31) 2024-08-02NoNoCurrent