Home NDC 67046-669 simvastatin
Product NDC 67046-669
11-digit product format 670460669
Labeler code 67046
Product ID 67046-669_7e2b672c-7078-8ef1-e053-2991aa0a1af6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Contract Pharmacy Services-PA
Application ANDA078155
Marketing category ANDA
Marketing start 2008-02-26
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 2020-12-31
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 · 36 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 67046-669-30 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 67046-669-30 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 67046-669-30 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 67046-669-30 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 67046-669-30 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 67046-669-30 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 67046-669-30 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 67046-669-30 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 67046-669-30 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 67046-669-30 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 67046-669-30 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 67046-669-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 67046-669-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 67046-669-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67046-669-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 67046-669-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 67046-669-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 67046-669-30 bd6a592717d7…303034d00443…
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 A078155-001 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 A078155-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 A078155-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 A078155-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 A078155-005 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05
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 · 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 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 67046-669-30 simvastatin 30 in 1 BLISTER PACK TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-669 SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] 2 Legacy NDC, 1 package rows 20181230_597c10d1-76fb-1408-e053-2991aa0a78d2.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 2 of 2 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join simvastatin SIMVASTATIN Aphena Pharma Solutions - Tennessee, LLC 121b0e00-abb7-4e07-a7b2-311be89fabb7 2019-03-25 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078155 application number: ANDA078155
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 67046-669-30 67046066930 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-669-30) 2017-09-18 0000-00-00 No No Current