Home NDC 51316-985 Ivermectin
Product NDC 51316-985
11-digit product format 513160985
Labeler code 51316
Product ID 51316-985_3802b5f4-b108-3614-e063-6294a90a6674
Type HUMAN OTC DRUG
Nonproprietary name Ivermectin
Dosage form LOTION
Route TOPICAL
Labeler CVS Pharmacy
Application ANDA210720
Marketing category ANDA
Marketing start 2025-06-20
Substance IVERMECTIN
Active strength 5 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 A210720-001 IVERMECTIN IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06
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 A210720-001 IVERMECTIN 0.5% LOTION / TOPICAL 2020-05-06 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 · 9 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 5 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 1246673 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 51316-985-08 Ivermectin 117 g in 1 TUBE LOTION 117 2 51316-985-08 Ivermectin 1 in 1 CARTON LOTION 1 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-985-08 51316098508 1 TUBE in 1 CARTON (51316-985-08) / 117 g in 1 TUBE 1 tube 2025-06-20 No No Current