Home NDC 63739-085-76 Econazole Nitrate
Product NDC 63739-085
Requested package NDC 63739-085-76
11-digit product format 637390085
Labeler code 63739
Product ID 63739-085_343f9dd6-5503-4867-a75b-7ba77b4b8868
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Econazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler McKesson Corporation
Application ANDA076574
Marketing category ANDA
Marketing start 2013-08-01
Marketing end 0000-00-00
Substance ECONAZOLE NITRATE
Active strength 10 mg/g
Pharmacologic classes Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 e64feba35796…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# 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 Marketing end Sample Exclude flag Status 63739-085-76 63739008576 1 TUBE in 1 CARTON (63739-085-76) > 85 g in 1 TUBE 1 tube 2021-06-24 0000-00-00 No No Current