simvastatin

Product NDC
0179-0242
11-digit product format
001790242
Labeler code
0179
Product ID
0179-0242_7b0d2dce-d057-1f38-e053-2a91aa0a22ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
KAISER FOUNDATION HOSPITALS
Application
ANDA078155
Marketing category
ANDA
Marketing start
2018-04-05
Marketing end
2019-09-30
Substance
SIMVASTATIN
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0179-0242DDiscontinued by firm2026-08-11
excluded packagepackage0179-02420179-0242-01DDiscontinued by firm2026-08-11

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 · 24 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 packagepackage0179-0242-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0179-0242-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0179-0242-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0179-0242-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0179-0242-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0179-0242-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0179-0242-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0179-0242-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0179-0242-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0179-0242-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0179-0242-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0179-0242-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078155-001SIMVASTATINSIMVASTATIN80MGTABLET / ORALAB2008-02-26
A078155-002SIMVASTATINSIMVASTATIN10MGTABLET / ORALAB2008-02-26
A078155-003SIMVASTATINSIMVASTATIN20MGTABLET / ORALAB2008-02-26
A078155-004SIMVASTATINSIMVASTATIN40MGTABLET / ORALAB2008-02-26
A078155-005SIMVASTATINSIMVASTATIN5MGTABLET / ORALAB2013-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078155-001AB
A078155-002AB
A078155-003AB
A078155-004AB
A078155-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078155-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078155-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-005AB15bbf6a4d5a75…

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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.aa8aed58-691b-472e-8e98-53d0d3f566862026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.7463b093-c2ee-49c3-a08a-e758de66422a2026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.c6b610ab-7367-4e61-9b4a-7ebbd1cf3d362026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepackc03ab80c-a3ae-4634-a76b-f53740db76f52026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNorthwind Health Company, LLCdb0f4c5a-e8e4-3ab1-e053-2995a90a1f9a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNorthwind Health Company, LLCf32d512f-86fa-b70f-e053-2a95a90afd012026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINQPharma, Inc.c80b823c-b30f-0a9d-e053-2995a90a31e92025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINAccord Healthcare, Inc.871251c0-36a1-4a32-9eab-ff6c1e925ca92025-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.56456210-2db5-4f0d-e054-00144ff8d46c2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepackb6d5fb21-a1a8-53e5-80d9-dde0eede5ef52024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepack356ed6a6-e467-4791-87ff-2ae7779fc1b02024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepackce3ac5e8-bdef-d195-e0a0-e1a982008efe2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepack79ca09cd-2396-4e50-b159-1f95671150672024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.54c236ce-69c2-06ef-e054-00144ff88e882024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.54c28733-eb99-10f6-e054-00144ff88e882024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.8ed46bb1-9f84-4418-e053-2a95a90abd4b2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.8e986df7-3020-6755-e053-2995a90aca372024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINA-S Medication Solutionsaaeebbc3-2608-41b5-8420-5a2a80316d392023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINProficient Rx LPca760e79-5d8c-4b36-9899-0d37e8e1f24e2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLCb5bebcd0-84e6-410d-af96-63834d262bad2021-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155