FDA.reportPublic FDA data

Lovastatin

Product NDC
51407-251
Requested package NDC
51407-251-60
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51407-25151407-251-60DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17a50c72e98297…
2026-08-01 22:54:322026-06A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17a50c72e98297…
2026-08-01 22:54:322026-06A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075551-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075551-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075551-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 51407-251-60
ndc (product): 51407-251
ndc11 (package): 51407025160
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

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

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
51407-251-605140702516060 TABLET in 1 BOTTLE (51407-251-60) 60 tablet2019-08-200000-00-00NoNoCurrent