FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiRQ8UL4C17S
Rxcui312139

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

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