Home NDC 78206-180 ZOCOR
Product NDC 78206-180
11-digit product format 782060180
Labeler code 78206
Product ID 78206-180_11256523-425c-48e8-afe1-e3a4e28c892e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SIMVASTATIN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Organon LLC
Application NDA019766
Marketing category NDA
Marketing start 2021-06-01
Substance SIMVASTATIN
Active strength 10 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing 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RLD 1991-12-23 N019766-005 ZOCOR SIMVASTATIN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-07-10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.
Additional Listing Data#
Finished product Yes
Brand name base ZOCOR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIMVASTATIN 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AGG2FN16EV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 104490 Internal RxNorm lookup 104491 Internal RxNorm lookup 152923 Internal RxNorm lookup 198211 Internal RxNorm lookup 312961 Internal RxNorm lookup 314231 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78206-180-01 ZOCOR 30 in 1 BOTTLE TABLET, FILM COATED 30 11 78206-180-02 ZOCOR 90 in 1 BOTTLE TABLET, FILM COATED 90 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-180 ZOCOR (SIMVASTATIN) TABLET, FILM COATED [ORGANON LLC] 11 Current NDC, Legacy NDC, 2 package rows 20250403_8f55d5de-5a4f-4a39-8c84-c53976dd6af9.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 78206-180-01 78206018001 30 TABLET, FILM COATED in 1 BOTTLE (78206-180-01) 2021-06-01 0000-00-00 No No Current 78206-180-02 78206018002 90 TABLET, FILM COATED in 1 BOTTLE (78206-180-02) 2021-06-01 0000-00-00 No No Current