FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Oxiconazole Nitrate
Listing expiration
2027-12-31

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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
04b740be-5bee-4b15-ac6d-f6699e2f435dProduct name120160414

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0358-302025-08-11C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-602025-08-11C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-902025-08-11C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-302025-07-29C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-602025-07-29C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-902025-07-29C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-302020-09-14C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-602020-09-14C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-902020-09-14C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-302020-07-22C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-602020-07-22C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
0168-0358-902020-07-22C16284748780-1ab0e2407-3313-f274-e053-dbdaa90a6471OXICONAZOLE 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 NDCProductDescriptionFormQuantityStrengthSPL version
0168-0358-30Oxiconazole Nitrate30 g in 1 TUBECREAM305
0168-0358-60Oxiconazole Nitrate60 g in 1 TUBECREAM605
0168-0358-90Oxiconazole Nitrate90 g in 1 TUBECREAM905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0358-30GM - Gram0168-0358eac06d55-e914-4b99-8a1f-3d8a8c0e859e12016-04-04
0168-0358-60GM - Gram0168-0358ebf50991-f79f-4115-8da3-8b5303f655df12016-04-04
0168-0358-90GM - Gram0168-03582a4c782b-647f-477b-877c-bfe946e9aee612016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0358OXICONAZOLE NITRATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20200915_aa368d2b-a5d2-49dd-86e1-5693b68b46f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312139oxiconazole nitrate 1 % Topical CreamPSNaa368d2b-a5d2-49dd-86e1-5693b68b46f45
312139oxiconazole 10 MG/ML Topical CreamSCDaa368d2b-a5d2-49dd-86e1-5693b68b46f45
312139oxiconazole (as oxiconazole nitrate) 1 % Topical CreamSYaa368d2b-a5d2-49dd-86e1-5693b68b46f45
312139oxiconazole 1 % Topical CreamSYaa368d2b-a5d2-49dd-86e1-5693b68b46f45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0358-300016803583030 g in 1 TUBE (0168-0358-30) 30 g2016-03-090000-00-00NoNoCurrent
0168-0358-600016803586060 g in 1 TUBE (0168-0358-60) 60 g2016-03-090000-00-00NoNoCurrent
0168-0358-900016803589090 g in 1 TUBE (0168-0358-90) 90 g2016-03-100000-00-00NoNoCurrent