Home NDC 21922-111 Econazole Nitrate
Product NDC 21922-111
11-digit product format 219220111
Labeler code 21922
Product ID 21922-111_aeba1cfd-c14e-45cb-b2fb-fedd2ad5dc74
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Econazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA076574
Marketing category ANDA
Marketing start 2026-07-01
Substance ECONAZOLE NITRATE
Active strength 10 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076574-001 ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076574-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Econazole Nitrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ECONAZOLE NITRATE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H438WYN10E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857366 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 21922-111-04 21922011104 1 TUBE in 1 CARTON (21922-111-04) / 15 g in 1 TUBE 1 tube 2026-07-01 No No Current 21922-111-05 21922011105 1 TUBE in 1 CARTON (21922-111-05) / 30 g in 1 TUBE 1 tube 2026-07-01 No No Current 21922-111-15 21922011115 1 TUBE in 1 CARTON (21922-111-15) / 85 g in 1 TUBE 1 tube 2026-07-01 No No Current