Lovastatin

Product NDC
68001-314
11-digit product format
680010314
Labeler code
68001
Product ID
68001-314_26682060-6c21-5cd7-e063-6394a90ab4dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078296
Marketing category
ANDA
Marketing start
2007-11-01
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

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Lovastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN10 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197903Internal RxNorm lookup
197904Internal RxNorm lookup
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
7b86160d-74a9-4774-b5b3-5641e686991fAvailable 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
68001-314-00Lovastatin100 in 1 BOTTLETABLET1008
68001-314-08Lovastatin1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-314-00EA - Each68001-3149e84e273-6c29-464b-8926-aca12306a23f12017-10-13
68001-314-08EA - Each68001-314d6535faf-c0d0-4760-b666-f5cb235ec67e12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-314LOVASTATIN TABLET [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 2 package rows20241116_7b86160d-74a9-4774-b5b3-5641e686991f.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
ndc (product): 68001-314
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 TabletPSN7b86160d-74a9-4774-b5b3-5641e686991f8
197904lovastatin 20 MG Oral TabletPSN7b86160d-74a9-4774-b5b3-5641e686991f8
197905lovastatin 40 MG Oral TabletPSN7b86160d-74a9-4774-b5b3-5641e686991f8
197903lovastatin 10 MG Oral TabletSCD7b86160d-74a9-4774-b5b3-5641e686991f8
197904lovastatin 20 MG Oral TabletSCD7b86160d-74a9-4774-b5b3-5641e686991f8
197905lovastatin 40 MG Oral TabletSCD7b86160d-74a9-4774-b5b3-5641e686991f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-314-0068001031400100 TABLET in 1 BOTTLE (68001-314-00) 100 tablet2017-02-070000-00-00NoNoCurrent
68001-314-08680010314081000 TABLET in 1 BOTTLE (68001-314-08) 1000 tablet2017-02-070000-00-00NoNoCurrent