Home NDC 59651-834 ELIMITE
Product NDC 59651-834
11-digit product format 596510834
Labeler code 59651
Product ID 59651-834_443c0446-ccba-4f52-83ed-4c3163f35807
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name permethrin
Dosage form CREAM
Route TOPICAL
Labeler Aurobindo Pharma Limited
Application NDA019855
Marketing category NDA
Marketing start 2024-01-22
Substance PERMETHRIN
Active strength 50 mg/g
Pharmacologic classes Pyrethrins [CS], Pyrethroid [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 N019855-001 ELIMITE PERMETHRIN 5% CREAM / TOPICAL AB RLD 1989-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019855-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD, RS 1989-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD, RS 1989-08-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD, RS 1989-08-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD, RS 1989-08-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019855-001 ELIMITE 5% CREAM / TOPICAL AB RLD 1989-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019855-001 ELIMITE 5% CREAM / TOPICAL RLD 1989-08-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ELIMITE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PERMETHRIN 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 509F88P9SZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106387 Internal RxNorm lookup 207485 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 59651-834-60 ELIMITE 1 in 1 CARTON CREAM 1 1 59651-834-60 ELIMITE 60 g in 1 TUBE CREAM 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-834 ELIMITE (PERMETHRIN) CREAM [AUROBINDO PHARMA LIMITED] 1 Current NDC, 2 package rows 20240125_443c0446-ccba-4f52-83ed-4c3163f35807.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 · 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 59651-834-60 59651083460 1 TUBE in 1 CARTON (59651-834-60) / 60 g in 1 TUBE 1 tube 2024-01-22 No No Current