Home NDC 0006-0740-54 ZOCOR
Product NDC 0006-0740
Requested package NDC 0006-0740-54
11-digit product format 000060740
Labeler code 0006
Product ID 0006-0740_41a60de3-6740-43c7-a8d7-7dbfd0a8d6a0
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 20 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 TALC INACTIVE INGREDIENT 7SEV7J4R1U ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 30
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0006-0740-54 00006074054 90 TABLET, FILM COATED in 1 BOTTLE (0006-0740-54) 1991-12-23 0000-00-00 No No Current