simvastatin

Product NDC
43063-008
Requested package NDC
43063-008-90
11-digit product format
430630008
Labeler code
43063
Product ID
43063-008_f162060e-dafd-fe8e-e053-2a95a90a5c4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078155
Marketing category
ANDA
Marketing start
2008-02-26
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43063-00843063-008-90DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-008-30EA - Each43063-0082705f4e2-c52d-4ebd-b5f3-c2e9b14aba9b12019-07-02
43063-008-90EA - Each43063-0086b5f4239-c043-4aa7-916b-f48817e1610112017-12-14

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-008-904306300089090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-008-90) 2017-11-070000-00-00NoNoCurrent