Lovastatin

Product NDC
72162-1739
11-digit product format
721621739
Labeler code
72162
Product ID
72162-1739_c3daa4ef-b136-479f-b7f7-48ef98c763d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
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
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
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197903Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
220a9b3c-c583-49e3-8bf0-d0c97dc9b829Available 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
72162-1739-0Lovastatin1000 in 1 BOTTLETABLET1000104
72162-1739-2Lovastatin100 in 1 BOTTLETABLET100104
72162-1739-4Lovastatin300 in 1 BOTTLETABLET300104
72162-1739-5Lovastatin500 in 1 BOTTLETABLET500104
72162-1739-6Lovastatin60 in 1 BOTTLETABLET60104
72162-1739-7Lovastatin120 in 1 BOTTLETABLET120104
72162-1739-9Lovastatin90 in 1 BOTTLETABLET90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1739-0EA - Each72162-173917466cd6-a469-40a8-a4e9-aeb10e754c6d12024-01-04
72162-1739-2EA - Each72162-1739fe38879a-6cdd-4f36-9199-0c94f1fe64a712023-12-05
72162-1739-4EA - Each72162-1739c74452e4-1acc-4bd0-ad82-538f902c10b212024-08-12
72162-1739-5EA - Each72162-173962e975f2-b710-4282-9404-15a7745e02bf12024-01-04
72162-1739-6EA - Each72162-1739c8012dff-2308-40b0-bbf3-a5367c41ee4f12024-08-12
72162-1739-7EA - Each72162-1739b5033e85-ab28-411c-83ed-0ee83c756d6f12023-12-05
72162-1739-9EA - Each72162-1739c8abddfb-bf98-4e83-b15c-363d218e3c4112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1739LOVASTATIN TABLET [BRYANT RANCH PREPACK]104Current NDC, 7 package rows20250403_220a9b3c-c583-49e3-8bf0-d0c97dc9b829.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
ndc (product): 72162-1739
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
197903lovastatin 10 MG Oral TabletPSN220a9b3c-c583-49e3-8bf0-d0c97dc9b829104
197903lovastatin 10 MG Oral TabletSCD220a9b3c-c583-49e3-8bf0-d0c97dc9b829104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1739-0721621739001000 TABLET in 1 BOTTLE (72162-1739-0) 1000 tablet2024-08-12NoNoCurrent
72162-1739-272162173902100 TABLET in 1 BOTTLE (72162-1739-2) 100 tablet2024-08-12NoNoCurrent
72162-1739-472162173904300 TABLET in 1 BOTTLE (72162-1739-4) 300 tablet2024-08-12NoNoCurrent
72162-1739-572162173905500 TABLET in 1 BOTTLE (72162-1739-5) 500 tablet2024-08-12NoNoCurrent
72162-1739-67216217390660 TABLET in 1 BOTTLE (72162-1739-6) 60 tablet2024-08-12NoNoCurrent
72162-1739-772162173907120 TABLET in 1 BOTTLE (72162-1739-7) 120 tablet2024-08-12NoNoCurrent
72162-1739-97216217390990 TABLET in 1 BOTTLE (72162-1739-9) 90 tablet2024-08-12NoNoCurrent