Home NDC 72578-120 ivermectin
Product NDC 72578-120
11-digit product format 725780120
Labeler code 72578
Product ID 72578-120_23a90438-439e-4a43-86a1-ea2343657d85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ivermectin
Dosage form CREAM
Route TOPICAL
Labeler Viona Pharmaceuticals Inc
Application ANDA215210
Marketing category ANDA
Marketing start 2023-06-10
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 A215210-001 IVERMECTIN IVERMECTIN 1% CREAM / TOPICAL AB 2022-08-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215210-001 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 A215210-001 IVERMECTIN 1% CREAM / TOPICAL AB 2022-08-02 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 A215210-001 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 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72578-120 IVERMECTIN CREAM [VIONA PHARMACEUTICALS INC] 5 Current NDC, 6 package rows 20240329_6b4a7400-d34c-4947-90e6-340f7087a702.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 72578-120-02 72578012002 1 TUBE in 1 CARTON (72578-120-02) / 60 g in 1 TUBE 1 tube 2023-06-10 No No Current 72578-120-06 72578012006 1 TUBE in 1 CARTON (72578-120-06) / 30 g in 1 TUBE 1 tube 2023-06-10 No No Current 72578-120-08 72578012008 1 TUBE in 1 CARTON (72578-120-08) / 45 g in 1 TUBE 1 tube 2023-06-10 No No Current