Lovastatin

Product NDC
0093-0576
11-digit product format
000930576
Labeler code
0093
Product ID
0093-0576_caf8172a-311b-447a-8c8b-e9d70c23c8e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075551
Marketing category
ANDA
Marketing start
2001-12-17
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 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
A075551-001LOVASTATINLOVASTATIN40MGTABLET / ORALAB2001-12-17
A075551-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2001-12-17
A075551-003LOVASTATINLOVASTATIN10MGTABLET / 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
A075551-001AB
A075551-002AB
A075551-003AB

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 06:07:402026-07A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-002LOVASTATIN20MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-003LOVASTATIN10MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075551-001LOVASTATIN40MGTABLET / ORALAB2001-12-171e350fbaab3a…

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 06:07:402026-07A075551-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075551-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075551-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075551-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075551-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075551-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075551-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075551-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075551-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075551-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075551-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075551-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075551-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075551-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075551-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075551-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075551-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075551-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075551-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075551-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075551-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075551-001AB11e350fbaab3a…

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 · 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
0e15feec-d27e-4861-8152-c5a8b8ccacd4Available 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
0093-0576-06Lovastatin60 in 1 BOTTLETABLET6021
0093-0576-10Lovastatin1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0576-06EA - Each0093-05760f1ec359-8b9b-4df6-a43c-32b93f24ec5612012-07-24
0093-0576-10EA - Each0093-05769c732b91-ecc3-487e-b7e5-ebb48fbb761212012-07-24
0093-0576-19EA - Each0093-057691148641-6846-4c8d-b5a1-0a0e15d3567b12012-07-24
0093-0576-93EA - Each0093-05761d788279-2f19-44b8-86fa-f6d6571dda7212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0576LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA, INC.]21Current NDC, Legacy NDC, 2 package rows20250227_0e15feec-d27e-4861-8152-c5a8b8ccacd4.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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINREMEDYREPACK INC.a902a95f-072a-4487-99a9-109a93f8b23c2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
LovastatinLOVASTATINGolden State Medical Supply, Inc.91332c54-1a27-4e6b-e053-2a95a90a42cd2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
LovastatinLOVASTATINA-S Medication Solutions4ff981e8-5c86-4b86-baa1-825551905ed82024-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
LovastatinLOVASTATINAphena Pharma Solutions - Tennessee, LLC7e96b174-3887-4908-9b9f-5ef93540f96a2023-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
LovastatinLOVASTATINTeva Pharmaceuticals USA, Inc.0e15feec-d27e-4861-8152-c5a8b8ccacd42020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551
ndc (product): 0093-0576
LovastatinLOVASTATINProficient Rx LP027bd594-6a0a-4e6d-bd3c-4f33fdb4166a2020-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075551
application number: ANDA075551

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN0e15feec-d27e-4861-8152-c5a8b8ccacd421
197904lovastatin 20 MG Oral TabletPSN0e15feec-d27e-4861-8152-c5a8b8ccacd421
197905lovastatin 40 MG Oral TabletPSN0e15feec-d27e-4861-8152-c5a8b8ccacd421
197903lovastatin 10 MG Oral TabletSCD0e15feec-d27e-4861-8152-c5a8b8ccacd421
197904lovastatin 20 MG Oral TabletSCD0e15feec-d27e-4861-8152-c5a8b8ccacd421
197905lovastatin 40 MG Oral TabletSCD0e15feec-d27e-4861-8152-c5a8b8ccacd421
197903lovastatin 10 MG Oral TabletPSN91332c54-1a27-4e6b-e053-2a95a90a42cd6
197904lovastatin 20 MG Oral TabletPSN91332c54-1a27-4e6b-e053-2a95a90a42cd6
197905lovastatin 40 MG Oral TabletPSN91332c54-1a27-4e6b-e053-2a95a90a42cd6
197903lovastatin 10 MG Oral TabletSCD91332c54-1a27-4e6b-e053-2a95a90a42cd6
197904lovastatin 20 MG Oral TabletSCD91332c54-1a27-4e6b-e053-2a95a90a42cd6
197905lovastatin 40 MG Oral TabletSCD91332c54-1a27-4e6b-e053-2a95a90a42cd6
197904lovastatin 20 MG Oral TabletPSN08e8e60d-b90e-419c-a8c7-5765627bd53b3
197904lovastatin 20 MG Oral TabletSCD08e8e60d-b90e-419c-a8c7-5765627bd53b3
197904lovastatin 20 MG Oral TabletPSN027bd594-6a0a-4e6d-bd3c-4f33fdb4166a1
197904lovastatin 20 MG Oral TabletSCD027bd594-6a0a-4e6d-bd3c-4f33fdb4166a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0576-060009305760660 TABLET in 1 BOTTLE (0093-0576-06) 60 tablet2001-12-170000-00-00NoNoCurrent
0093-0576-10000930576101000 TABLET in 1 BOTTLE (0093-0576-10) 1000 tablet2001-12-170000-00-00NoNoCurrent