Home NDC 71705-050 Moxidectin
Product NDC 71705-050
11-digit product format 717050050
Labeler code 71705
Product ID 71705-050_410f2173-90f1-2f73-e063-6394a90a0aa9
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
Substance MOXIDECTIN
Active strength 2 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Moxidectin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOXIDECTIN 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NGU5H31YO9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2049015 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71705-050-01 Moxidectin 500 in 1 BOTTLE, PLASTIC TABLET 500 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71705-050 MOXIDECTIN TABLET [MEDICINES DEVELOPMENT FOR GLOBAL HEALTH] 19 Current NDC, Legacy NDC, 1 package rows 20250213_6eb02ae9-9065-176f-e053-2991aa0ac891.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71705-050-01 71705005001 500 TABLET in 1 BOTTLE, PLASTIC (71705-050-01) 500 tablet 2019-12-02 0000-00-00 No No Current