Home Applications 019766 Application 019766
Type NDA
Sponsor MSD MERCK CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZOCOR SIMVASTATIN TABLET;ORAL 5MG Yes No 002 ZOCOR SIMVASTATIN TABLET;ORAL 10MG Yes No 003 ZOCOR SIMVASTATIN TABLET;ORAL 20MG Yes No 004 ZOCOR SIMVASTATIN TABLET;ORAL 40MG Yes No 005 ZOCOR SIMVASTATIN TABLET;ORAL 80MG Yes Yes
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RLD 1991-12-23 N019766-005 ZOCOR SIMVASTATIN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10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UTC 2026-02 N019766-005 ZOCOR 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019766-001 ZOCOR 5MG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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-0543 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0543 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0543 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0543 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0543 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0726 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0735 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0735 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0735 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0735 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0735 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0740 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0740 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0740 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0740 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0740 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0749 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0749 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0749 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0749 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 0006-0749 ZOCOR SIMVASTATIN Merck Sharp & Dohme Corp. NDA Current 78206-179 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-179 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-179 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-180 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-180 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-180 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-181 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-181 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-181 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-182 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-182 ZOCOR SIMVASTATIN Organon LLC NDA Current 78206-182 ZOCOR SIMVASTATIN Organon LLC NDA Current