Lovastatin

Product NDC
51407-251
11-digit product format
514070251
Labeler code
51407
Product ID
51407-251_46049ec7-69c6-fab7-e063-6294a90acd9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075551
Marketing category
ANDA
Marketing start
2001-12-17
Substance
LOVASTATIN
Active strength
10 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51407-25151407-251-60DDiscontinued by firm2026-08-17
excluded packagepackage51407-25151407-251-90DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0551407-251-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0551407-251-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2651407-251-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2651407-251-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3151407-251-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3151407-251-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2851407-251-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2851407-251-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2151407-251-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2151407-251-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1051407-251-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1051407-251-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3151407-251-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3151407-251-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2051407-251-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2051407-251-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1051407-251-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1051407-251-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0851407-251-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0851407-251-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0351407-251-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0351407-251-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0951407-251-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0951407-251-90557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075551-001LOVASTATINLOVASTATIN40MGTABLET / ORALAB2001-12-17
A075551-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2001-12-17
A075551-003LOVASTATINLOVASTATIN10MGTABLET / ORALAB2001-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075551-001AB
A075551-002AB
A075551-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-171e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075551-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075551-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075551-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075551-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075551-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075551-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075551-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075551-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075551-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075551-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075551-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075551-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075551-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Lovastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9LHU78OQFDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197903Internal RxNorm lookup
197904Internal RxNorm lookup
197905Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
91332c54-1a27-4e6b-e053-2a95a90a42cdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508
f1ae760e-e8ec-b0b4-fb1b-2db7c49fcec5Product name120140508
fecc3d5d-ff9a-60ad-1a3a-6cb9b21df758Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-251-10Lovastatin1000 in 1 BOTTLETABLET10006
51407-251-60Lovastatin60 in 1 BOTTLETABLET606
51407-251-90Lovastatin90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-251-10EA - Each51407-2516b2648ca-528d-469c-8859-ba19493e2e4e12019-12-10
51407-251-60EA - Each51407-251ab419de3-9c6f-4679-8c62-4234abda641712019-12-10
51407-251-90EA - Each51407-2518197b9f8-3db9-41b7-87b6-be4a632e93b012019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-251LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY]5Current NDC, Legacy NDC, 3 package rows20231230_91332c54-1a27-4e6b-e053-2a95a90a42cd.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINREMEDYREPACK INC.a902a95f-072a-4487-99a9-109a93f8b23c2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
LovastatinLOVASTATINGolden State Medical Supply, Inc.91332c54-1a27-4e6b-e053-2a95a90a42cd2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
ndc (product): 51407-251
LovastatinLOVASTATINA-S Medication Solutions4ff981e8-5c86-4b86-baa1-825551905ed82024-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
LovastatinLOVASTATINAphena Pharma Solutions - Tennessee, LLC7e96b174-3887-4908-9b9f-5ef93540f96a2023-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
LovastatinLOVASTATINTeva Pharmaceuticals USA, Inc.0e15feec-d27e-4861-8152-c5a8b8ccacd42020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
LovastatinLOVASTATINProficient Rx LP027bd594-6a0a-4e6d-bd3c-4f33fdb4166a2020-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN91332c54-1a27-4e6b-e053-2a95a90a42cd6
197904lovastatin 20 MG Oral TabletPSN91332c54-1a27-4e6b-e053-2a95a90a42cd6
197905lovastatin 40 MG Oral TabletPSN91332c54-1a27-4e6b-e053-2a95a90a42cd6
197903lovastatin 10 MG Oral TabletSCD91332c54-1a27-4e6b-e053-2a95a90a42cd6
197904lovastatin 20 MG Oral TabletSCD91332c54-1a27-4e6b-e053-2a95a90a42cd6
197905lovastatin 40 MG Oral TabletSCD91332c54-1a27-4e6b-e053-2a95a90a42cd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-251-10514070251101000 TABLET in 1 BOTTLE (51407-251-10) 1000 tablet2019-08-200000-00-00NoNoCurrent
51407-251-605140702516060 TABLET in 1 BOTTLE (51407-251-60) 60 tablet2019-08-200000-00-00NoNoCurrent
51407-251-905140702519090 TABLET in 1 BOTTLE (51407-251-90) 90 tablet2019-08-200000-00-00NoNoCurrent