Home NDC 68308-701 IVERMECTIN
Product NDC 68308-701
11-digit product format 683080701
Labeler code 68308
Product ID 68308-701_180415ea-bcf7-49ef-92f4-41d58324d752
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IVERMECTIN
Dosage form CREAM
Route TOPICAL
Labeler Mayne Pharma Inc.
Application NDA206255
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-01-08
Substance IVERMECTIN
Active strength 10 mg/g
Pharmacologic classes Antiparasitic [EPC], Pediculicide [EPC]
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 N206255-001 SOOLANTRA IVERMECTIN 1% CREAM / TOPICAL AB RLD, RS 2014-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N206255-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206255-001 10206939 2034-03-13 U-1631 2019-02-19 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 N206255-001 9782425 2034-03-13 U-1631 2018-01-05
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 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206255-001 SOOLANTRA 1% CREAM / TOPICAL RLD, RS 2014-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206255-001 SOOLANTRA 1% CREAM / TOPICAL RLD, RS 2014-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 12 · 451 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 11033565 2024-04-22 Drug product 2021-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 7550440 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8080530 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8093219 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8415311 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8470788 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8815816 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 03ed91905a0d…
Additional Listing Data#
Finished product Yes
Brand name base IVERMECTIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IVERMECTIN 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8883YP2R6D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1598068 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 68308-701-45 IVERMECTIN 1 in 1 CARTON CREAM 1 1 68308-701-45 IVERMECTIN 45 g in 1 TUBE CREAM 45 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-701 IVERMECTIN CREAM [MAYNE PHARMA INC.] 1 Current NDC, 2 package rows 20240108_39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68308-701-45 68308070145 1 TUBE in 1 CARTON (68308-701-45) / 45 g in 1 TUBE 1 tube 2024-01-08 No No Current