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 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 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.
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 2026-08-01 22:54:32 2026-06 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N206255-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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
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