Home NDC 76420-619 Ivermectin
Product NDC 76420-619
11-digit product format 764200619
Labeler code 76420
Product ID 76420-619_06f2293c-2cf4-70d4-e063-6394a90a3a56
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ivermectin
Dosage form TABLET
Route ORAL
Labeler Asclemed USA, 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 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 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.
Product history page 1 of 2 · 42 observed 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 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204154-001 IVERMECTIN 3MG TABLET / ORAL AB 2014-10-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 76420-619-20 Ivermectin 2 in 1 CARTON TABLET 2 1 76420-619-20 Ivermectin 10 in 1 BLISTER PACK TABLET 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-619 IVERMECTIN TABLET [ASCLEMED USA, INC.] 1 Current NDC, 2 package rows 20231006_014e33e7-c07d-4feb-a2cf-7cd160b1facd.zip
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 · 4 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 76420-619-20 76420061920 2 BLISTER PACK in 1 CARTON (76420-619-20) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2023-10-05 No No Current