Home NDC 51079-454 Simvastatin
Product NDC 51079-454
11-digit product format 510790454
Labeler code 51079
Product ID 51079-454_9af1b4b7-abf7-2bc7-e053-2a95a90a6153
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA076052
Marketing category ANDA
Marketing start 2006-07-10
Marketing end 2020-04-30
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 0000-00-00
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 51079-454-20 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 51079-454-20 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 51079-454-20 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 51079-454-20 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 51079-454-20 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 51079-454-20 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 51079-454-20 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 51079-454-20 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 51079-454-20 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 51079-454-20 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 51079-454-20 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 51079-454-20 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076052-001 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 A076052-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 A076052-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 A076052-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 A076052-005 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL 2006-12-20
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 · 215 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 2026-09-14 22:38:34 2026-08 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 03ed91905a0d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2