Home NDC 51004-1097 Scandonest L
Product NDC 51004-1097
11-digit product format 510041097
Labeler code 51004
Product ID 51004-1097_59fcd689-a6a3-4739-a982-6b41c249de7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mepivacaine Hydrochloride and Levonordefrin
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Novocol Pharmaceutical of Canada, Inc
Application ANDA088388
Marketing category ANDA
Marketing start 2013-06-27
Marketing end 0000-00-00
Substance MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN
Active strength 20 mg/mL; mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
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 · 30 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51004-1097-8 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51004-1097-8 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51004-1097-8 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51004-1097-8 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51004-1097-8 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51004-1097-8 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51004-1097-8 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51004-1097-8 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51004-1097-8 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 51004-1097-8 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 51004-1097-8 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 51004-1097-8 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 51004-1097-8 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 51004-1097-8 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 51004-1097-8 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088388-001 SCANDONEST L LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10
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 2 · 41 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 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION 1984-10-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088388-001 SCANDONEST L 0.05MG/ML;2% INJECTABLE / INJECTION RS 1984-10-10 cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVONORDEFRIN ACTIVE INGREDIENT V008L6478D SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1 MEPIVACAINE HYDROCHLORIDE ACTIVE INGREDIENT 4VFX2L7EM5 SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1 LEVONORDEFRIN ACTIVE MOIETY V008L6478D SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1 MEPIVACAINE ACTIVE MOIETY B6E06QE59J SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1 POTASSIUM METABISULFITE INACTIVE INGREDIENT 65OE787Q7W SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SCANDONEST L (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC] 1