Lovastatin

Product NDC
71610-775
11-digit product format
716100775
Labeler code
71610
Product ID
71610-775_2db77596-4171-4597-ba55-045b97d142ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075991-001LOVASTATIN10MGTABLET / ORALAB2002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A075991-002LOVASTATIN20MGTABLET / ORALAB2002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A075991-003LOVASTATIN40MGTABLET / ORALABRS2002-06-05caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075991-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075991-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075991-003AB1caaa826d4ba7…
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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN40 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
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
0399c35c-513d-48e6-aa20-e8434e3b18d5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71610-775-30Lovastatin30 in 1 BOTTLE, PLASTICTABLET301
71610-775-45Lovastatin45 in 1 BOTTLE, PLASTICTABLET451
71610-775-53Lovastatin60 in 1 BOTTLE, PLASTICTABLET601
71610-775-60Lovastatin90 in 1 BOTTLE, PLASTICTABLET901
71610-775-80Lovastatin180 in 1 BOTTLE, PLASTICTABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-775-30EA - Each71610-7757b6eaadc-310f-4b2b-805b-108f085b7dce12024-04-05
71610-775-45EA - Each71610-77579910528-f609-454a-b548-0dd838e534aa12024-04-05
71610-775-53EA - Each71610-77546ae082f-accd-4b2a-893d-886ae896782f12024-04-05
71610-775-60EA - Each71610-775ce4ee593-74a9-43fa-ba0c-1fec2ed0ade512024-04-05
71610-775-80EA - Each71610-775cf55d556-6868-4032-b312-c7cd5a9b7c4112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-775LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 5 package rows20240125_0399c35c-513d-48e6-aa20-e8434e3b18d5.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
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
197905lovastatin 40 MG Oral TabletPSN0399c35c-513d-48e6-aa20-e8434e3b18d51
197905lovastatin 40 MG Oral TabletSCD0399c35c-513d-48e6-aa20-e8434e3b18d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-775-307161007753030 TABLET in 1 BOTTLE, PLASTIC (71610-775-30) 30 tablet2024-01-22NoNoCurrent
71610-775-457161007754545 TABLET in 1 BOTTLE, PLASTIC (71610-775-45) 45 tablet2024-01-22NoNoCurrent
71610-775-537161007755360 TABLET in 1 BOTTLE, PLASTIC (71610-775-53) 60 tablet2024-01-22NoNoCurrent
71610-775-607161007756090 TABLET in 1 BOTTLE, PLASTIC (71610-775-60) 90 tablet2024-01-22NoNoCurrent
71610-775-8071610077580180 TABLET in 1 BOTTLE, PLASTIC (71610-775-80) 180 tablet2024-01-22NoNoCurrent