Lovastatin

Product NDC
63629-6386
11-digit product format
636296386
Labeler code
63629
Product ID
63629-6386_dbb49531-030f-450d-8b4f-e8902f6a900e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078296
Marketing category
ANDA
Marketing start
2007-11-01
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-6386DDiscontinued by firm2026-08-17
excluded packagepackage63629-638663629-6386-1DDiscontinued by firm2026-08-17
excluded packagepackage63629-638663629-6386-2DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-6386-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-6386-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-6386-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-6386-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-6386-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-6386-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-6386-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-6386-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-6386-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-6386-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-6386-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-6386-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-6386-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-6386-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-6386-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-6386-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-6386-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-6386-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-6386-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-6386-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-6386-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-6386-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-6386-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-6386-2557ba5c1ecfa…9c80585c8c6e…

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…

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