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 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 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 2026-08-18 06:07:40 2026-07 A216863-001 IVERMECTIN 3MG TABLET / ORAL AB 2026-02-26 caaa826d4ba7…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 2026-08-18 06:07:40 2026-07 A216863-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216863-001 AB 1 a50c72e98297…
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
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 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