Lovastatin

Product NDC
68788-8287
11-digit product format
687888287
Labeler code
68788
Product ID
68788-8287_89cfb920-9cab-43b2-a6d9-33e6e62fbeb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078296
Marketing category
ANDA
Marketing start
2022-11-17
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-8287DDiscontinued by firm2026-08-17
excluded packagepackage68788-828768788-8287-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-828768788-8287-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-828768788-8287-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-828768788-8287-9DDiscontinued by firm2026-08-17

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
A078296-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2008-03-14
A078296-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2007-11-01
A078296-003LOVASTATINLOVASTATIN40MGTABLET / ORALAB2007-11-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078296-001AB
A078296-002AB
A078296-003AB

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 06:07:402026-07A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078296-002LOVASTATIN20MGTABLET / ORALAB2007-11-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078296-003LOVASTATIN40MGTABLET / ORALAB2007-11-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078296-001LOVASTATIN10MGTABLET / ORALAB2008-03-141e350fbaab3a…

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 06:07:402026-07A078296-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078296-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078296-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078296-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078296-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078296-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078296-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078296-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078296-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078296-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078296-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078296-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078296-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078296-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078296-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078296-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078296-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078296-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078296-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078296-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078296-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078296-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078296-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078296-001AB11e350fbaab3a…

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
68788-8287-1Lovastatin100 in 1 BOTTLETABLET1004
68788-8287-3Lovastatin30 in 1 BOTTLETABLET304
68788-8287-6Lovastatin60 in 1 BOTTLETABLET604
68788-8287-9Lovastatin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8287-1EA - Each68788-8287c422810e-865f-46a0-bb4f-17790e47bcc612023-01-09
68788-8287-3EA - Each68788-8287d29d95b0-9d02-4358-95ae-1bbed07fd96112023-01-09
68788-8287-6EA - Each68788-82870b89cf29-c3e7-43e7-9c78-c6f2385da2e212023-01-09
68788-8287-9EA - Each68788-828794339418-7af5-4689-9dc6-346cfce0081312023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8287LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20240703_8a77e539-a31e-43a4-a53e-a4204aa38558.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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINPD-Rx Pharmaceuticals, Inc.e75b5808-ec66-4da7-90bc-e53611aa1b342026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.397949f9-ce60-424f-9902-90e65a34f4de2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.22c9f2d8-7bcd-4415-bbc8-5057200339662026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINBryant Ranch Prepack030c0f79-6bb5-4876-bf8e-b7a25b25dd382026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINBryant Ranch Prepackf5f265a6-2aa5-4205-9159-40133ae93ac02026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINBluePoint Laboratories7b86160d-74a9-4774-b5b3-5641e686991f2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINREMEDYREPACK INC.ff040b3c-6790-40d7-bd64-a4073b4a20452026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINLupin Pharmaceuticals, Inc.df7ddf4f-d569-431e-81f1-9129d70431502026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINLegacy Pharmaceutical Packaging, LLCa4f02fa1-3281-46fa-bd52-323e2644b6f82026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNorthwind Health Company, LLCf308fe1c-23a9-6409-e053-2995a90abfd92026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNorthwind Health Company, LLCca59cbd4-a4c1-aebe-e053-2a95a90ae9682026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNorthwind Health Company, LLCf99e0b4c-e757-4ccd-e053-6294a90ab7222026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINA-S Medication Solutions06b8c398-ce2e-42c1-b1a8-73cc59a080db2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINBoswell Pharmacy Services LLC d/b/a BPS Wholesale2eeb34ac-f973-e7d9-e063-6294a90a076e2025-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNuCare Pharmaceuticals, Inc.50217921-97a7-6ff2-e054-00144ff88e882025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINA-S Medication Solutions02aae38d-ee9d-4c09-a155-b69f221ed3e92024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNCS HealthCare of KY, LLC dba Vangard Labs3af47e72-082d-42ad-bde0-294f8101b45c2024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNuCare Pharmaceuticals,Inc.19b2bb87-1dc7-cd72-e063-6394a90a0f732024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINNuCare Pharmaceuticals,Inc.1ac7ffb9-860a-fbb6-e063-6294a90a590f2024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296
LovastatinLOVASTATINProficient Rx LP2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb2022-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078296
application number: ANDA078296

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN8a77e539-a31e-43a4-a53e-a4204aa385584
197903lovastatin 10 MG Oral TabletSCD8a77e539-a31e-43a4-a53e-a4204aa385584

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8287-168788828701100 TABLET in 1 BOTTLE (68788-8287-1) 100 tablet2022-11-170000-00-00NoNoCurrent
68788-8287-36878882870330 TABLET in 1 BOTTLE (68788-8287-3) 30 tablet2022-11-170000-00-00NoNoCurrent
68788-8287-66878882870660 TABLET in 1 BOTTLE (68788-8287-6) 60 tablet2022-11-170000-00-00NoNoCurrent
68788-8287-96878882870990 TABLET in 1 BOTTLE (68788-8287-9) 90 tablet2022-11-170000-00-00NoNoCurrent