Home NDC 0168-0358 Oxiconazole Nitrate
Product NDC 0168-0358
11-digit product format 001680358
Labeler code 0168
Product ID 0168-0358_413f9391-fa2d-4449-b25d-fd11376f231e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxiconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application NDA019828
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-03-09
Substance OXICONAZOLE 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 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.
Additional Listing Data#
Finished product Yes
Brand name base Oxiconazole Nitrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXICONAZOLE 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 RQ8UL4C17S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312139 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0168-0358-30 2025-08-11 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-60 2025-08-11 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-90 2025-08-11 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-30 2025-07-29 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-60 2025-07-29 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-90 2025-07-29 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-30 2020-09-14 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-60 2020-09-14 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-90 2020-09-14 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-30 2020-07-22 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-60 2020-07-22 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE. 0168-0358-90 2020-07-22 OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0168-0358-30 Oxiconazole Nitrate 30 g in 1 TUBE CREAM 30 5 0168-0358-60 Oxiconazole Nitrate 60 g in 1 TUBE CREAM 60 5 0168-0358-90 Oxiconazole Nitrate 90 g in 1 TUBE CREAM 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0358 OXICONAZOLE NITRATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 3 package rows 20200915_aa368d2b-a5d2-49dd-86e1-5693b68b46f4.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 · 1 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 0168-0358-30 00168035830 30 g in 1 TUBE (0168-0358-30) 30 g 2016-03-09 0000-00-00 No No Current 0168-0358-60 00168035860 60 g in 1 TUBE (0168-0358-60) 60 g 2016-03-09 0000-00-00 No No Current 0168-0358-90 00168035890 90 g in 1 TUBE (0168-0358-90) 90 g 2016-03-10 0000-00-00 No No Current