Lovastatin

Product NDC
43063-692
11-digit product format
430630692
Labeler code
43063
Product ID
43063-692_2fb37b45-9a7a-b6cd-e063-6294a90abe42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
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
2026-12-31
Current FDA listing
Yes

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
A075991-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2002-06-05
A075991-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2002-06-05
A075991-003LOVASTATINLOVASTATIN40MGTABLET / ORALABRS2002-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075991-001AB
A075991-002AB
A075991-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-058072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075991-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075991-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075991-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075991-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075991-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075991-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075991-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075991-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075991-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075991-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075991-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075991-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075991-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075991-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075991-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075991-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075991-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075991-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075991-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075991-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075991-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075991-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075991-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075991-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075991-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075991-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN20 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
70e2bf86-4a78-4dfb-b6b1-8eb95f63684dAvailable 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
43063-692-30Lovastatin30 in 1 BOTTLE, PLASTICTABLET3023
43063-692-90Lovastatin90 in 1 BOTTLE, PLASTICTABLET9023
43063-692-93Lovastatin180 in 1 BOTTLE, PLASTICTABLET18023
43063-692-95Lovastatin1000 in 1 BOTTLE, PLASTICTABLET100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-692-30EA - Each43063-692d5521ece-1652-478d-af34-765d2c3846ee12023-09-05
43063-692-90EA - Each43063-6923e914b1d-0172-4756-8046-3b3adddcae0312016-09-02
43063-692-93EA - Each43063-6920d908a28-2107-4713-b650-dc2996ee52fc12016-09-02
43063-692-95EA - Each43063-6927520871f-d436-47c4-80f9-0a21513ab96d12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-692LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 4 package rows20250309_70e2bf86-4a78-4dfb-b6b1-8eb95f63684d.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINREMEDYREPACK INC.9438d8a0-ca5b-4676-aab9-d0241ccff6c92026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINPreferred Pharmaceuticals Inc.56680dfa-abe6-4587-b222-364315fd78f42026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.ea4df37b-21e9-4dc3-83af-1be1b50bfdc92026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINBryant Ranch Prepack7fd9d5c7-8025-4049-8b5b-ae3d22db507f2026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINNorthwind Health Company, LLCdb47ddae-c574-427f-e053-2a95a90aae482026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINA-S Medication Solutionsdd7a223e-7fc5-4eb0-9bd7-2f9a2d6b41732025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINA-S Medication Solutionsbfb889a4-5751-4706-9fa7-f48672c1bc082025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINBryant Ranch Prepack220a9b3c-c583-49e3-8bf0-d0c97dc9b8292025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINPD-Rx Pharmaceuticals, Inc.c37206ae-52f1-4192-9ab9-3044247cf58d2025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINPD-Rx Pharmaceuticals, Inc.ac86821f-d741-4ab1-bd03-ce8797dd4f342025-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINPD-Rx Pharmaceuticals, Inc.70e2bf86-4a78-4dfb-b6b1-8eb95f63684d2025-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
ndc (product): 43063-692
LovastatinLOVASTATINPD-Rx Pharmaceuticals, Inc.eea93a4b-f804-4b9c-aabf-e906f03c1e802025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINBoswell Pharmacy Services LLC d/b/a BPS Wholesale2eff3e5e-8746-048e-e063-6294a90a38c42025-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINCarlsbad Technology, Inc.0a680e13-0356-4e08-a7fe-78b96ba51b9d2025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINBryant Ranch Prepackc871a6a7-67a4-4ac1-b102-3f1604625c7d2024-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINNuCare Pharmaceuticals, Inc.415c2698-7787-49f8-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINNuCare Pharmaceuticals, Inc.4444573e-9df1-01e6-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINBryant Ranch Prepack8d8199ca-df39-4eb8-a905-dee3ab7e29732024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINBryant Ranch Prepack5684ceb8-a5b2-4fb4-92be-14aabcea38712024-08-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991
LovastatinLOVASTATINBryant Ranch Prepackad905651-6e3a-4140-aa37-d91e5f37c0f02024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075991
application number: ANDA075991

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN70e2bf86-4a78-4dfb-b6b1-8eb95f63684d23
197904lovastatin 20 MG Oral TabletSCD70e2bf86-4a78-4dfb-b6b1-8eb95f63684d23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-692-304306306923030 TABLET in 1 BOTTLE, PLASTIC (43063-692-30) 30 tablet2023-07-31NoNoCurrent
43063-692-904306306929090 TABLET in 1 BOTTLE, PLASTIC (43063-692-90) 90 tablet2016-07-260000-00-00NoNoCurrent
43063-692-9343063069293180 TABLET in 1 BOTTLE, PLASTIC (43063-692-93) 180 tablet2016-07-260000-00-00NoNoCurrent
43063-692-95430630692951000 TABLET in 1 BOTTLE, PLASTIC (43063-692-95) 1000 tablet2022-10-030000-00-00NoNoCurrent