Home NDC 62559-285 Oxistat
Product NDC 62559-285
11-digit product format 625590285
Labeler code 62559
Product ID 62559-285_c38f8751-f5da-4333-b12a-2ca8c1816a32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxiconazole nitrate
Dosage form LOTION
Route TOPICAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA020209
Marketing category NDA
Marketing start 2022-09-12
Substance OXICONAZOLE NITRATE
Active strength 10 mg/mL
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 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 N020209-001 OXISTAT OXICONAZOLE NITRATE EQ 1% BASE LOTION / TOPICAL RLD 1992-09-30
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 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD 1992-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD 1992-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020209-001 OXISTAT EQ 1% BASE LOTION / TOPICAL RLD, RS 1992-09-30 f41ea6bd6efb…
Additional Listing Data#
Finished product Yes
Brand name base Oxistat
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXICONAZOLE NITRATE 10 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207249 Internal RxNorm lookup 312140 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-285 OXISTAT (OXICONAZOLE NITRATE) LOTION [ANI PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 6 package rows 20220912_64ef2286-0f56-4a8a-b07b-4a597f078ae0.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 62559-285-06 62559028506 6 BOTTLE in 1 CARTON (62559-285-06) / 7 mL in 1 BOTTLE 6 bottle 2022-09-12 0000-00-00 No No Current 62559-285-30 62559028530 1 BOTTLE in 1 CARTON (62559-285-30) / 30 mL in 1 BOTTLE 1 bottle 2022-09-12 0000-00-00 No No Current 62559-285-60 62559028560 1 BOTTLE in 1 CARTON (62559-285-60) / 60 mL in 1 BOTTLE 1 bottle 2022-09-12 0000-00-00 No No Current