Home NDC 0006-0726 ZOCOR
Product NDC 0006-0726
11-digit product format 000060726
Labeler code 0006
Product ID 0006-0726_8b9717e7-dd82-4a2e-afdc-a7bf9c97b479
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SIMVASTATIN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme Corp.
Application NDA019766
Marketing category NDA
Marketing start 1991-12-23
Marketing end 0000-00-00
Substance SIMVASTATIN
Active strength 5 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0006-0726-31 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0006-0726-31 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0006-0726-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0006-0726-31 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0006-0726-31 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0006-0726-31 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0006-0726-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0006-0726-31 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0006-0726-31 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0006-0726-31 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0006-0726-31 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0006-0726-31 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019766-001 ZOCOR SIMVASTATIN 5MG TABLET / ORAL AB RLD 1991-12-23 N019766-002 ZOCOR SIMVASTATIN 10MG TABLET / ORAL AB RLD 1991-12-23 N019766-003 ZOCOR SIMVASTATIN 20MG TABLET / ORAL AB RLD 1991-12-23 N019766-004 ZOCOR SIMVASTATIN 40MG TABLET / ORAL AB RLD 1991-12-23 N019766-005 ZOCOR SIMVASTATIN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019766-001 ZOCOR 5MG TABLET / ORAL AB RLD 1991-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019766-002 ZOCOR 10MG TABLET / ORAL AB RLD 1991-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019766-003 ZOCOR 20MG TABLET / ORAL AB RLD 1991-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019766-004 ZOCOR 40MG TABLET / ORAL AB RLD 1991-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019766-005 ZOCOR 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019766-001 ZOCOR 5MG TABLET / ORAL AB RLD 1991-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019766-002 ZOCOR 10MG TABLET / ORAL AB RLD 1991-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019766-003 ZOCOR 20MG TABLET / ORAL AB RLD 1991-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019766-004 ZOCOR 40MG TABLET / ORAL AB RLD 1991-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019766-005 ZOCOR 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019766-001 ZOCOR 5MG TABLET / ORAL AB RLD 1991-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019766-002 ZOCOR 10MG TABLET / ORAL AB RLD 1991-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019766-003 ZOCOR 20MG TABLET / ORAL AB RLD 1991-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019766-004 ZOCOR 40MG TABLET / ORAL AB RLD 1991-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019766-005 ZOCOR 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019766-001 ZOCOR 5MG TABLET / ORAL AB RLD 1991-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019766-002 ZOCOR 10MG TABLET / ORAL AB RLD 1991-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019766-003 ZOCOR 20MG TABLET / ORAL AB RLD 1991-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019766-004 ZOCOR 40MG TABLET / ORAL AB RLD 1991-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019766-005 ZOCOR 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019766-001 ZOCOR 5MG TABLET / ORAL AB RLD 1991-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019766-002 ZOCOR 10MG TABLET / ORAL AB RLD 1991-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019766-003 ZOCOR 20MG TABLET / ORAL AB RLD 1991-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019766-004 ZOCOR 40MG TABLET / ORAL AB RLD 1991-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019766-005 ZOCOR 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019766-001 ZOCOR 5MG TABLET / ORAL AB RLD 1991-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019766-002 ZOCOR 10MG TABLET / ORAL AB RLD 1991-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019766-003 ZOCOR 20MG TABLET / ORAL AB RLD 1991-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019766-004 ZOCOR 40MG TABLET / ORAL AB RLD 1991-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019766-005 ZOCOR 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019766-001 ZOCOR 5MG TABLET / ORAL AB RLD 1991-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019766-002 ZOCOR 10MG TABLET / ORAL AB RLD 1991-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019766-003 ZOCOR 20MG TABLET / ORAL AB RLD 1991-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019766-004 ZOCOR 40MG TABLET / ORAL AB RLD 1991-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019766-005 ZOCOR 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019766-001 ZOCOR 5MG TABLET / ORAL AB RLD 1991-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019766-002 ZOCOR 10MG TABLET / ORAL AB RLD 1991-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019766-003 ZOCOR 20MG TABLET / ORAL AB RLD 1991-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019766-004 ZOCOR 40MG TABLET / ORAL AB RLD 1991-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019766-005 ZOCOR 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZOCOR SIMVASTATIN Organon LLC 8f55d5de-5a4f-4a39-8c84-c53976dd6af9 2025-03-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 019766 application number: NDA019766