Home NDC 68645-263 Simvastatin
Product NDC 68645-263
11-digit product format 686450263
Labeler code 68645
Product ID 68645-263_82a864ad-1652-405f-bbfa-b8ece0089165
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Legacy Pharmaceutical Packaging
Application ANDA077752
Marketing category ANDA
Marketing start 2006-12-20
Marketing end 0000-00-00
Substance SIMVASTATIN
Active strength 80 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68645-263-54 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68645-263-54 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68645-263-54 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68645-263-54 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68645-263-54 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68645-263-54 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68645-263-54 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68645-263-54 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68645-263-54 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68645-263-54 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68645-263-54 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68645-263-54 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68645-263-54 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68645-263-54 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68645-263-54 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68645-263-54 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68645-263-54 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68645-263-54 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68645-263-54 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68645-263-54 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68645-263-54 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68645-263-54 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A077752-001 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 A077752-002 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 A077752-003 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 A077752-004 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 A077752-005 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL AB 2008-01-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 · 210 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 2026-08-18 06:07:40 2026-07 A077752-001 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077752-002 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077752-003 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077752-004 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077752-005 SIMVASTATIN 5MG TABLET / ORAL AB 2008-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077752-001 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077752-002 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077752-003 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077752-004 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077752-005 SIMVASTATIN 5MG TABLET / ORAL AB 2008-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077752-001 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077752-002 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077752-003 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077752-004 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077752-005 SIMVASTATIN 5MG TABLET / ORAL AB 2008-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077752-001 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077752-002 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077752-003 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077752-004 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077752-005 SIMVASTATIN 5MG TABLET / ORAL AB 2008-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077752-001 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077752-002 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077752-003 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077752-004 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077752-005 SIMVASTATIN 5MG TABLET / ORAL AB 2008-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077752-001 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077752-002 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077752-003 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077752-004 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077752-005 SIMVASTATIN 5MG TABLET / ORAL AB 2008-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077752-001 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077752-002 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077752-003 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077752-004 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077752-005 SIMVASTATIN 5MG TABLET / ORAL AB 2008-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077752-001 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077752-002 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077752-003 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077752-004 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077752-005 SIMVASTATIN 5MG TABLET / ORAL AB 2008-01-23 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68645-263-54 Simvastatin 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68645-263 SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] 3 Legacy NDC, 1 package rows 20120828_4a81b757-0a64-4ed4-86f4-57aeb349105f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68645-263-54 68645026354 30 in 1 BOTTLE Historical