Oxiconazole Nitrate

Product NDC
51672-1359
11-digit product format
516721359
Labeler code
51672
Product ID
51672-1359_38efa4f4-a3f2-fd03-e063-6394a90aac00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxiconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205076
Marketing category
ANDA
Marketing start
2016-03-07
Substance
OXICONAZOLE NITRATE
Active strength
10 mg/g
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205076-001OXICONAZOLE NITRATEOXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A205076-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-0784e616aacf4f…
2026-08-18 06:07:402026-07A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-073f01610625f2…
2019-09-15 20:21 UTC2019-09A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205076-001OXICONAZOLE NITRATEEQ 1% BASECREAM / TOPICALAB2016-03-07f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205076-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A205076-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205076-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205076-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205076-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205076-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205076-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205076-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205076-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205076-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205076-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205076-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205076-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205076-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205076-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205076-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205076-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205076-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205076-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205076-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205076-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205076-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205076-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205076-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205076-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205076-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205076-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205076-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205076-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205076-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205076-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205076-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205076-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205076-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205076-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205076-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205076-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205076-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205076-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205076-001AB1f41ea6bd6efb…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxiconazole Nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXICONAZOLE NITRATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RQ8UL4C17SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312139Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04477378-cccc-4db3-9e1b-5c1d6a00bd13Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
04b740be-5bee-4b15-ac6d-f6699e2f435dProduct name120160414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1359-1Oxiconazole Nitrate1 in 1 CARTONCREAM17
51672-1359-1Oxiconazole Nitrate15 g in 1 TUBECREAM157
51672-1359-2Oxiconazole Nitrate30 g in 1 TUBECREAM307
51672-1359-2Oxiconazole Nitrate1 in 1 CARTONCREAM17
51672-1359-3Oxiconazole Nitrate1 in 1 CARTONCREAM17
51672-1359-3Oxiconazole Nitrate60 g in 1 TUBECREAM607
51672-1359-8Oxiconazole Nitrate1 in 1 CARTONCREAM17
51672-1359-8Oxiconazole Nitrate90 g in 1 TUBECREAM907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1359-2GM - Gram51672-1359a2b33705-0733-4763-97ac-069309ac7b2112016-04-04
51672-1359-3GM - Gram51672-1359bbd47b28-7ec5-415a-9c60-8623e404a3bc12016-04-04
51672-1359-8GM - Gram51672-13594c9b1ca2-b80f-4fec-a067-2941c21f172312016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1359OXICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 8 package rows20241222_04477378-cccc-4db3-9e1b-5c1d6a00bd13.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxiconazole NitrateOXICONAZOLE NITRATESun Pharmaceutical Industries, Inc.04477378-cccc-4db3-9e1b-5c1d6a00bd132025-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205076
application number: ANDA205076
ndc (product): 51672-1359

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312139oxiconazole nitrate 1 % Topical CreamPSN04477378-cccc-4db3-9e1b-5c1d6a00bd137
312139oxiconazole 10 MG/ML Topical CreamSCD04477378-cccc-4db3-9e1b-5c1d6a00bd137
312139oxiconazole (as oxiconazole nitrate) 1 % Topical CreamSY04477378-cccc-4db3-9e1b-5c1d6a00bd137
312139oxiconazole 1 % Topical CreamSY04477378-cccc-4db3-9e1b-5c1d6a00bd137

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1359-1516721359011 TUBE in 1 CARTON (51672-1359-1) / 15 g in 1 TUBE1 tube2016-03-070000-00-00NoNoCurrent
51672-1359-2516721359021 TUBE in 1 CARTON (51672-1359-2) / 30 g in 1 TUBE1 tube2016-03-070000-00-00NoNoCurrent
51672-1359-3516721359031 TUBE in 1 CARTON (51672-1359-3) / 60 g in 1 TUBE1 tube2016-03-070000-00-00NoNoCurrent
51672-1359-8516721359081 TUBE in 1 CARTON (51672-1359-8) / 90 g in 1 TUBE1 tube2016-03-070000-00-00NoNoCurrent