Home NDC 68071-2242 Ivermectin
Product NDC 68071-2242
11-digit product format 680712242
Labeler code 68071
Product ID 68071-2242_1d76541f-80d8-2a55-e063-6294a90aa5f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ivermectin
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA204154
Marketing category ANDA
Marketing start 2014-11-15
Substance IVERMECTIN
Active strength 3 mg/1
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 A204154-001 IVERMECTIN IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204154-001 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 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 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 A204154-001 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 · 4 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 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 68071-2242-3 Ivermectin 2 in 1 CARTON TABLET 2 3 68071-2242-3 Ivermectin 10 in 1 BLISTER PACK TABLET 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2242 IVERMECTIN TABLET [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240719_ad6539f2-94de-1bc5-e053-2a95a90a4cf2.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-2242-3 68071224203 2 BLISTER PACK in 1 CARTON (68071-2242-3) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2014-11-15 0000-00-00 No No Current