Lovastatin

Product NDC
67544-106
11-digit product format
675440106
Labeler code
67544
Product ID
67544-106_8eccf91e-8dd6-406a-bfe2-a45d49012d13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions -
Application
ANDA075636
Marketing category
ANDA
Marketing start
2001-12-17
Marketing end
0000-00-00
Substance
LOVASTATIN
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reducta
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-106DDiscontinued by firm2026-08-17
excluded packagepackage67544-10667544-106-15DDiscontinued by firm2026-08-17
excluded packagepackage67544-10667544-106-30DDiscontinued by firm2026-08-17
excluded packagepackage67544-10667544-106-45DDiscontinued by firm2026-08-17
excluded packagepackage67544-10667544-106-53DDiscontinued by firm2026-08-17
excluded packagepackage67544-10667544-106-60DDiscontinued by firm2026-08-17
excluded packagepackage67544-10667544-106-80DDiscontinued 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 2 · 84 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 packagepackage67544-106-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-106-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-106-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-106-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-106-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-106-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-106-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-106-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-106-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-106-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-106-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-106-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-106-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-106-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-106-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-106-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-106-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-106-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-106-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-106-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-106-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-106-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-106-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-106-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-106-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-106-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-106-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-106-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-106-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-106-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-106-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-106-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-106-80cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-106-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-106-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-106-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-106-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-106-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-106-80302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-106-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-106-53302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-106-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-106-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-106-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-106-80ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-106-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-106-53ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-106-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-106-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-106-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-106-800efc9e666f02…f202fb6c5f17…

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
A075636-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2001-12-17
A075636-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2001-12-17
A075636-003LOVASTATINLOVASTATIN40MGTABLET / 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
A075636-001AB
A075636-002AB
A075636-003AB

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 06:07:402026-07A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075636-001LOVASTATIN10MGTABLET / 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 06:07:402026-07A075636-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075636-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075636-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075636-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075636-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075636-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075636-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075636-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075636-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075636-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075636-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075636-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075636-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075636-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075636-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075636-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075636-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075636-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075636-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075636-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075636-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075636-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075636-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075636-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075636-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075636-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075636-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075636-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075636-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075636-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075636-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075636-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075636-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075636-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075636-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075636-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075636-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075636-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075636-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075636-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-106-15EA - Each67544-106b22eb7cd-0104-466e-9d21-8bc3a13d6bfc12014-06-03
67544-106-30EA - Each67544-106f36b99be-251d-48ba-a760-a73a9093388112014-06-03
67544-106-45EA - Each67544-106de56ce9f-3d3e-4e6c-b5fc-ba93bceab81312014-06-03
67544-106-53EA - Each67544-1064684f183-7d58-4a65-81bd-9c471c7ba2f812014-06-03
67544-106-60EA - Each67544-106f13a05fc-40d2-4e35-83b3-0419f752d1e012014-06-03
67544-106-80EA - Each67544-1069d97f90e-4d8c-4050-8c62-65a23efaf6b012014-06-03

DailyMed Socrata Ingredients#