FDA.reportPublic FDA data

Lovastatin

Product NDC
67046-451
Requested package NDC
67046-451-30
11-digit product format
670460451
Labeler code
67046
Product ID
67046-451_5a966d64-68b6-403b-e053-2991aa0a4417
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA075636
Marketing category
ANDA
Marketing start
2017-10-02
Marketing end
0000-00-00
Substance
LOVASTATIN
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage67046-45167046-451-30IInactivated 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
A075636-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2001-12-17
A075636-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2001-12-17
A075636-003LOVASTATINLOVASTATIN40MGTABLET / 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
A075636-001AB
A075636-002AB
A075636-003AB

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 22:54:322026-06A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17a50c72e98297…
2026-08-01 22:54:322026-06A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17a50c72e98297…
2026-08-01 22:54:322026-06A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075636-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075636-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075636-003AB1a50c72e98297…

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
67046-451-072022-01-28C16284748780-1d6a99b39-e9b9-a426-e053-dadaa90af4c2450 Lovastatin 20 mg 451 Lovastatin 40 mg Lovastatin Tablets, USP
67046-451-142022-01-28C16284748780-1d6a99b39-e9b9-a426-e053-dadaa90af4c2450 Lovastatin 20 mg 451 Lovastatin 40 mg Lovastatin Tablets, USP
67046-451-152022-01-28C16284748780-1d6a99b39-e9b9-a426-e053-dadaa90af4c2450 Lovastatin 20 mg 451 Lovastatin 40 mg Lovastatin Tablets, USP
67046-451-202022-01-28C16284748780-1d6a99b39-e9b9-a426-e053-dadaa90af4c2450 Lovastatin 20 mg 451 Lovastatin 40 mg Lovastatin Tablets, USP
67046-451-212022-01-28C16284748780-1d6a99b39-e9b9-a426-e053-dadaa90af4c2450 Lovastatin 20 mg 451 Lovastatin 40 mg Lovastatin Tablets, USP
67046-451-282022-01-28C16284748780-1d6a99b39-e9b9-a426-e053-dadaa90af4c2450 Lovastatin 20 mg 451 Lovastatin 40 mg Lovastatin Tablets, USP
67046-451-302022-01-28C16284748780-1d6a99b39-e9b9-a426-e053-dadaa90af4c2450 Lovastatin 20 mg 451 Lovastatin 40 mg Lovastatin Tablets, USP
67046-451-602022-01-28C16284748780-1d6a99b39-e9b9-a426-e053-dadaa90af4c2450 Lovastatin 20 mg 451 Lovastatin 40 mg Lovastatin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-451-07Lovastatin7 in 1 BLISTER PACKTABLET71
67046-451-14Lovastatin14 in 1 BLISTER PACKTABLET141
67046-451-15Lovastatin15 in 1 BLISTER PACKTABLET151
67046-451-20Lovastatin20 in 1 BLISTER PACKTABLET201
67046-451-21Lovastatin21 in 1 BLISTER PACKTABLET211
67046-451-28Lovastatin28 in 1 BLISTER PACKTABLET281
67046-451-30Lovastatin30 in 1 BLISTER PACKTABLET301
67046-451-60Lovastatin60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-451LOVASTATIN TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20171003_5a966d64-68b3-403b-e053-2991aa0a4417.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN5a966d64-68b3-403b-e053-2991aa0a44171
197905lovastatin 40 MG Oral TabletPSN5a966d64-68b3-403b-e053-2991aa0a44171
197904lovastatin 20 MG Oral TabletSCD5a966d64-68b3-403b-e053-2991aa0a44171
197905lovastatin 40 MG Oral TabletSCD5a966d64-68b3-403b-e053-2991aa0a44171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-451-306704604513030 TABLET in 1 BLISTER PACK (67046-451-30) 30 tablet2017-10-020000-00-00NoNoCurrent