lovastatin

Product NDC
53489-607
11-digit product format
534890607
Labeler code
53489
Product ID
53489-607_36f83432-6257-4cda-9902-510ec4b0975c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Mutual Pharmaceutical Company, Inc.
Application
ANDA077520
Marketing category
ANDA
Marketing start
2006-04-14
Marketing end
0000-00-00
Substance
LOVASTATIN
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53489-607IInactivated by FDA2026-10-05
excluded packagepackage53489-60753489-607-01IInactivated by FDA2026-10-05
excluded packagepackage53489-60753489-607-03IInactivated by FDA2026-10-05
excluded packagepackage53489-60753489-607-05IInactivated by FDA2026-10-05
excluded packagepackage53489-60753489-607-06IInactivated by FDA2026-10-05
excluded packagepackage53489-60753489-607-07IInactivated by FDA2026-10-05
excluded packagepackage53489-60753489-607-10IInactivated by FDA2026-10-05

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 3 · 154 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-607-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-607-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-607-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-607-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-607-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-607-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-607-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-607-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-607-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-607-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-607-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-607-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-607-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-607-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-607-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-607-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-607-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-607-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-607-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-607-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-607-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-607-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-607-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-607-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-607-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-607-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-607-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-607-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-607-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-607-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-607-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-607-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-607-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-607-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-607-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-607-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-607-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-607-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-607-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-607-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-607-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-607-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-607-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-607-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-607-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-607-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-607-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-607-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-607-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-607-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-607-100efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077520-001LOVASTATINLOVASTATIN10MGTABLET / ORAL2006-04-14
A077520-002LOVASTATINLOVASTATIN20MGTABLET / ORAL2006-04-14
A077520-003LOVASTATINLOVASTATIN40MGTABLET / ORAL2006-04-14

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-1484e616aacf4f…
2026-09-14 22:38:342026-08A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-1484e616aacf4f…
2026-09-14 22:38:342026-08A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-1484e616aacf4f…
2026-08-18 06:07:402026-07A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077520-002LOVASTATIN20MGTABLET / ORAL2006-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077520-003LOVASTATIN40MGTABLET / ORAL2006-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077520-001LOVASTATIN10MGTABLET / ORAL2006-04-14301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A077520-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077520-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077520-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077520-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077520-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077520-003AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-607-01lovastatin100 in 1 BOTTLE, PLASTICTABLET1005
53489-607-03lovastatin250 in 1 BOTTLE, PLASTICTABLET2505
53489-607-05lovastatin500 in 1 BOTTLE, PLASTICTABLET5005
53489-607-06lovastatin60 in 1 BOTTLE, PLASTICTABLET605
53489-607-07lovastatin30 in 1 BOTTLE, PLASTICTABLET305
53489-607-10lovastatin1000 in 1 BOTTLE, PLASTICTABLET10005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lovastatinACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
lovastatinACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
aluminum oxideINACTIVE INGREDIENTLMI26O6933LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-607LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5Legacy NDC, 6 package rows20130105_caf7c3af-8256-4557-af40-e8143e9af9f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSNcaf7c3af-8256-4557-af40-e8143e9af9f15
197904lovastatin 20 MG Oral TabletPSNcaf7c3af-8256-4557-af40-e8143e9af9f15
197905lovastatin 40 MG Oral TabletPSNcaf7c3af-8256-4557-af40-e8143e9af9f15
197903lovastatin 10 MG Oral TabletSCDcaf7c3af-8256-4557-af40-e8143e9af9f15
197904lovastatin 20 MG Oral TabletSCDcaf7c3af-8256-4557-af40-e8143e9af9f15
197905lovastatin 40 MG Oral TabletSCDcaf7c3af-8256-4557-af40-e8143e9af9f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53489-607-0153489060701100 in 1 BOTTLE, PLASTICHistorical
53489-607-0353489060703250 in 1 BOTTLE, PLASTICHistorical
53489-607-0553489060705500 in 1 BOTTLE, PLASTICHistorical
53489-607-065348906070660 in 1 BOTTLE, PLASTICHistorical
53489-607-075348906070730 in 1 BOTTLE, PLASTICHistorical
53489-607-10534890607101000 in 1 BOTTLE, PLASTICHistorical