Home NDC 72578-223 Ivermectin
Product NDC 72578-223
11-digit product format 725780223
Labeler code 72578
Product ID 72578-223_74497c59-8194-466d-a95f-3bf838ff99f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ivermectin
Dosage form TABLET
Route ORAL
Labeler Viona Pharmaceuticals Inc
Application ANDA216863
Marketing category ANDA
Marketing start 2026-02-27
Substance IVERMECTIN
Active strength 3 mg/1
Pharmacologic classes Antiparasitic [EPC], Pediculicide [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A216863-001 IVERMECTIN IVERMECTIN 3MG TABLET / ORAL AB 2026-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216863-001 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216863-001 IVERMECTIN 3MG TABLET / ORAL AB 2026-02-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216863-001 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Ivermectin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IVERMECTIN 3 mg/1
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 311207 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 72578-223-30 Ivermectin 10 in 1 BLISTER PACK TABLET 10 1 72578-223-83 Ivermectin 2 in 1 CARTON TABLET 2 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72578-223-30 72578022330 10 in 1 BLISTER PACK Historical 72578-223-83 72578022383 2 BLISTER PACK in 1 CARTON (72578-223-83) / 10 TABLET in 1 BLISTER PACK (72578-223-30) 2 blister pack 2026-02-27 No No Current