Home NDC 71335-2946 Ivermectin
Product NDC 71335-2946
11-digit product format 713352946
Labeler code 71335
Product ID 71335-2946_41dc4fab-4adc-eed2-e063-6294a90a4000
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ivermectin
Dosage form CREAM
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA210225
Marketing category ANDA
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 A210225-001 IVERMECTIN IVERMECTIN 1% CREAM / TOPICAL AB 2020-04-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210225-001 AB
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 A210225-001 IVERMECTIN 1% CREAM / TOPICAL AB 2020-04-13 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 A210225-001 AB 1 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 · 3 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 71335-2946-1 Ivermectin 1 in 1 CARTON CREAM 1 100 71335-2946-1 Ivermectin 45 g in 1 TUBE CREAM 45 100
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-2946-1 71335294601 1 TUBE in 1 CARTON (71335-2946-1) / 45 g in 1 TUBE 1 tube 2025-10-23 No No Current