Simvastatin

Product NDC
68788-9835
11-digit product format
687889835
Labeler code
68788
Product ID
68788-9835_bb6f6fcf-a62b-4223-adb2-de81bd89c763
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077752
Marketing category
ANDA
Marketing start
2012-03-29
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9835DDiscontinued by firm2026-08-17
excluded packagepackage68788-983568788-9835-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-983568788-9835-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-983568788-9835-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-983568788-9835-9DDiscontinued 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 · 60 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 packagepackage68788-9835-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9835-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9835-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9835-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9835-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9835-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9835-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9835-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9835-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9835-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9835-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9835-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9835-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9835-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9835-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9835-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9835-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9835-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9835-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9835-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9835-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9835-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9835-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9835-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9835-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9835-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9835-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9835-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9835-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9835-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9835-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9835-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9835-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9835-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9835-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9835-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9835-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9835-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9835-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9835-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9835-6367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9835-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9835-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9835-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9835-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9835-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9835-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9835-3557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077752-001SIMVASTATINSIMVASTATIN10MGTABLET / ORALAB2006-12-20
A077752-002SIMVASTATINSIMVASTATIN20MGTABLET / ORALAB2006-12-20
A077752-003SIMVASTATINSIMVASTATIN40MGTABLET / ORALAB2006-12-20
A077752-004SIMVASTATINSIMVASTATIN80MGTABLET / ORALAB2006-12-20
A077752-005SIMVASTATINSIMVASTATIN5MGTABLET / ORALAB2008-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A077752-001AB
A077752-002AB
A077752-003AB
A077752-004AB
A077752-005AB

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077752-001SIMVASTATIN10MGTABLET / ORALAB2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077752-002SIMVASTATIN20MGTABLET / ORALAB2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077752-003SIMVASTATIN40MGTABLET / ORALAB2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077752-004SIMVASTATIN80MGTABLET / ORALAB2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077752-005SIMVASTATIN5MGTABLET / ORALAB2008-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077752-001SIMVASTATIN10MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077752-002SIMVASTATIN20MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077752-003SIMVASTATIN40MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077752-004SIMVASTATIN80MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077752-005SIMVASTATIN5MGTABLET / ORALAB2008-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-001SIMVASTATIN10MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-002SIMVASTATIN20MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-003SIMVASTATIN40MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-004SIMVASTATIN80MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-005SIMVASTATIN5MGTABLET / ORALAB2008-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077752-001SIMVASTATIN10MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077752-002SIMVASTATIN20MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077752-003SIMVASTATIN40MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077752-004SIMVASTATIN80MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077752-005SIMVASTATIN5MGTABLET / ORALAB2008-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-001SIMVASTATIN10MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-002SIMVASTATIN20MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-003SIMVASTATIN40MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-004SIMVASTATIN80MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-005SIMVASTATIN5MGTABLET / ORALAB2008-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-001SIMVASTATIN10MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-002SIMVASTATIN20MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-003SIMVASTATIN40MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-004SIMVASTATIN80MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-005SIMVASTATIN5MGTABLET / ORALAB2008-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-001SIMVASTATIN10MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-002SIMVASTATIN20MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-003SIMVASTATIN40MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-004SIMVASTATIN80MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-005SIMVASTATIN5MGTABLET / ORALAB2008-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-001SIMVASTATIN10MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-002SIMVASTATIN20MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-003SIMVASTATIN40MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-004SIMVASTATIN80MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-005SIMVASTATIN5MGTABLET / ORALAB2008-01-232680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077752-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077752-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077752-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077752-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077752-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077752-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077752-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077752-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077752-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077752-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077752-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077752-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077752-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077752-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077752-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077752-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077752-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077752-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077752-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077752-005AB12680178bc6a6…