FDA.reportPublic FDA data

Lovastatin

Product NDC
53002-5701
Requested package NDC
53002-5701-3
11-digit product format
530025701
Labeler code
53002
Product ID
53002-5701_a5d5d8d8-175a-441f-87b4-88a9a5261913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075551
Marketing category
ANDA
Marketing start
2001-12-17
Marketing end
0000-00-00
Substance
LOVASTATIN
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage53002-570153002-5701-3IInactivated by FDA2026-07-31

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
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 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-5701-02025-01-30C16284748780-1f386c64a-206e-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
53002-5701-32025-01-30C16284748780-1f386c64a-206e-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
53002-5701-62025-01-30C16284748780-1f386c64a-206e-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
53002-5701-02023-06-08C16284748780-1f386c64a-206e-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
53002-5701-32023-06-08C16284748780-1f386c64a-206e-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
53002-5701-62023-06-08C16284748780-1f386c64a-206e-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
53002-5701-02023-01-30C16284748780-1f386c64a-206e-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
53002-5701-32023-01-30C16284748780-1f386c64a-206e-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
53002-5701-62023-01-30C16284748780-1f386c64a-206e-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5701-0Lovastatin100 in 1 BOTTLETABLET1003
53002-5701-3Lovastatin30 in 1 BOTTLETABLET303
53002-5701-6Lovastatin60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5701LOVASTATIN TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20230609_08e8e60d-b90e-419c-a8c7-5765627bd53b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN08e8e60d-b90e-419c-a8c7-5765627bd53b3
197904lovastatin 20 MG Oral TabletSCD08e8e60d-b90e-419c-a8c7-5765627bd53b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5701-35300257010330 TABLET in 1 BOTTLE (53002-5701-3) 30 tablet2020-01-010000-00-00NoNoCurrent