Home NDC 21922-021 Permethrin
Product NDC 21922-021
11-digit product format 219220021
Labeler code 21922
Product ID 21922-021_b8ac86be-821c-4a76-a6f2-f86e63e76c09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Permethrin Cream 5% w/w
Dosage form CREAM
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA211303
Marketing category ANDA
Marketing start 2019-04-08
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 A211303-001 PERMETHRIN PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211303-001 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 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Permethrin
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106387 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 21922-021-07 Permethrin 1 in 1 CARTON CREAM 1 5 21922-021-07 Permethrin 60 g in 1 TUBE CREAM 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-021 PERMETHRIN (PERMETHRIN CREAM 5% W/W) CREAM [ENCUBE ETHICALS PRIVATE LIMITED] 4 Current NDC, Legacy NDC, 2 package rows 20250523_35225d0a-3bde-4c7d-bdf9-81661012e77c.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 Marketing end Sample Exclude flag Status 21922-021-07 21922002107 1 TUBE in 1 CARTON (21922-021-07) / 60 g in 1 TUBE 1 tube 2019-04-08 0000-00-00 No No Current