Lovastatin

Product NDC
67544-225
11-digit product format
675440225
Labeler code
67544
Product ID
67544-225_0c57c932-2720-4ab0-8ae4-24983c75130b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075636
Marketing category
ANDA
Marketing start
2001-12-17
Marketing end
2022-05-31
Substance
LOVASTATIN
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct67544-225DDiscontinued by firm2026-08-17
excluded packagepackage67544-22567544-225-15DDiscontinued by firm2026-08-17
excluded packagepackage67544-22567544-225-30DDiscontinued by firm2026-08-17
excluded packagepackage67544-22567544-225-45DDiscontinued by firm2026-08-17
excluded packagepackage67544-22567544-225-53DDiscontinued by firm2026-08-17
excluded packagepackage67544-22567544-225-60DDiscontinued by firm2026-08-17
excluded packagepackage67544-22567544-225-80DDiscontinued 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 packagepackage67544-225-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-225-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-225-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-225-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-225-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-225-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-225-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-225-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-225-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-225-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-225-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-225-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-225-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-225-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-225-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-225-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-225-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-225-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-225-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-225-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-225-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-225-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-225-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-225-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-225-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-225-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-225-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-225-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-225-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-225-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-225-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-225-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-225-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-225-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-225-80cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-225-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-225-53302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-225-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-225-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-225-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-225-80302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-225-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-225-53ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-225-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-225-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-225-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-225-80ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-225-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-225-530efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-225-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-225-450efc9e666f02…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
67544-225-15EA - Each67544-225b3eba9c5-5730-40c5-8884-dc1268e7747412014-06-03
67544-225-30EA - Each67544-225744505b3-a33c-4b0c-9d89-6d38566f9f4612014-06-03
67544-225-45EA - Each67544-22592b519ec-72f5-4a6b-b582-a3eca32e774b12014-06-03
67544-225-53EA - Each67544-2259f73f164-2e3d-47df-8762-ef619c48917312014-09-03
67544-225-60EA - Each67544-2254289e2ae-ba1a-4de0-8dd6-d19a0b204b1a12014-06-03
67544-225-80EA - Each67544-2252e109dc5-606c-46c1-8b78-3f5d3cec8e9612014-06-03

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-225-156754402251515 TABLET in 1 BOTTLE, PLASTIC (67544-225-15) 15 tablet2016-11-102022-05-31NoNoCurrent
67544-225-306754402253030 TABLET in 1 BOTTLE, PLASTIC (67544-225-30) 30 tablet2004-09-222022-05-31NoNoCurrent
67544-225-456754402254545 TABLET in 1 BOTTLE, PLASTIC (67544-225-45) 45 tablet2016-10-252022-05-31NoNoCurrent
67544-225-536754402255360 TABLET in 1 BOTTLE, PLASTIC (67544-225-53) 60 tablet2016-10-252022-05-31NoNoCurrent
67544-225-606754402256090 TABLET in 1 BOTTLE, PLASTIC (67544-225-60) 90 tablet2004-08-242022-05-31NoNoCurrent
67544-225-8067544022580180 TABLET in 1 BOTTLE, PLASTIC (67544-225-80) 180 tablet2004-09-162022-05-31NoNoCurrent