Home NDC 10337-358-90 Oxistat
Product NDC 10337-358
Requested package NDC 10337-358-90
11-digit product format 103370358
Labeler code 10337
Product ID 10337-358_c31b3c09-29fc-45ca-a742-3b5a9f553517
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxiconazole nitrate
Dosage form CREAM
Route TOPICAL
Labeler PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application NDA019828
Marketing category NDA
Marketing start 1988-12-30
Marketing end 0000-00-00
Substance OXICONAZOLE NITRATE
Active strength 10 mg/g
Pharmacologic classes Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 11 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…
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 N019828-001 OXISTAT OXICONAZOLE NITRATE EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019828-001 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 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 10337-358-30 2020-09-11 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%* 10337-358-42 2020-09-11 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%* 10337-358-60 2020-09-11 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%* 10337-358-66 2020-09-11 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%* 10337-358-90 2020-09-11 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%* 10337-358-30 2020-07-22 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%* 10337-358-42 2020-07-22 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%* 10337-358-60 2020-07-22 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%* 10337-358-66 2020-07-22 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%* 10337-358-90 2020-07-22 OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*
DailyMed Socrata Ingredients# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxiconazole Nitrate OXICONAZOLE NITRATE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC aa368d2b-a5d2-49dd-86e1-5693b68b46f4 2026-01-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 019828 application number: NDA019828
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10337-358-90 10337035890 1 TUBE in 1 CARTON (10337-358-90) > 90 g in 1 TUBE 1 tube 2009-08-19 0000-00-00 No No Current