Home NDC 71705-051-01 Moxidectin
Product NDC 71705-051
Requested package NDC 71705-051-01
11-digit product format 717050051
Labeler code 71705
Product ID 71705-051_d506c256-d6b7-0a58-e053-2995a90ae660
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Moxidectin
Dosage form TABLET
Route ORAL
Labeler Medicines Development for Global Health
Application NDA210867
Marketing category NDA
Marketing start 2019-12-02
Marketing end 0000-00-00
Substance MOXIDECTIN
Active strength 2 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N210867-001 MOXIDECTIN MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210867-001 NPP 2028-02-07 N210867-001 ODE-528 2032-02-07
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 · 42 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 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 e64feba35796…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Moxidectin MOXIDECTIN Medicines Development for Global Health 6eb02ae9-9065-176f-e053-2991aa0ac891 2026-07-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 210867 application number: NDA210867
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71705-051-01 71705005101 500 TABLET in 1 BOTTLE, PLASTIC (71705-051-01) 500 tablet 2019-12-02 0000-00-00 No No Current