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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXICONAZOLE NITRATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRQ8UL4C17S
Rxcui207249, 312140

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-285-06Oxistat6 in 1 CARTONLOTION65
62559-285-06Oxistat7 mL in 1 BOTTLELOTION75
62559-285-30Oxistat1 in 1 CARTONLOTION15
62559-285-30Oxistat30 mL in 1 BOTTLELOTION305
62559-285-60Oxistat60 mL in 1 BOTTLELOTION605
62559-285-60Oxistat1 in 1 CARTONLOTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-285-30ML - Milliliter62559-285c4d482d2-33ef-49e8-87d3-ffcbbae0742012023-01-09
62559-285-60ML - Milliliter62559-285bdfbf12f-a998-42da-87df-f759e12a340112023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-285OXISTAT (OXICONAZOLE NITRATE) LOTION [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 6 package rows20220912_64ef2286-0f56-4a8a-b07b-4a597f078ae0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312140oxiconazole nitrate 1 % Topical LotionPSN64ef2286-0f56-4a8a-b07b-4a597f078ae05
207249Oxistat 1 % Topical LotionPSN64ef2286-0f56-4a8a-b07b-4a597f078ae05
207249oxiconazole 10 MG/ML Topical Lotion [Oxistat]SBD64ef2286-0f56-4a8a-b07b-4a597f078ae05
312140oxiconazole 10 MG/ML Topical LotionSCD64ef2286-0f56-4a8a-b07b-4a597f078ae05
312140oxiconazole (as oxiconazole nitrate) 1 % Topical LotionSY64ef2286-0f56-4a8a-b07b-4a597f078ae05
312140oxiconazole 1 % Topical LotionSY64ef2286-0f56-4a8a-b07b-4a597f078ae05
207249Oxistat (as oxiconazole nitrate) 1 % Topical LotionSY64ef2286-0f56-4a8a-b07b-4a597f078ae05
207249Oxistat 1 % Topical LotionSY64ef2286-0f56-4a8a-b07b-4a597f078ae05
207249Oxistat 10 MG/ML Topical LotionSY64ef2286-0f56-4a8a-b07b-4a597f078ae05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-285-06625590285066 BOTTLE in 1 CARTON (62559-285-06) / 7 mL in 1 BOTTLE6 bottle2022-09-120000-00-00NoNoCurrent
62559-285-30625590285301 BOTTLE in 1 CARTON (62559-285-30) / 30 mL in 1 BOTTLE1 bottle2022-09-120000-00-00NoNoCurrent
62559-285-60625590285601 BOTTLE in 1 CARTON (62559-285-60) / 60 mL in 1 BOTTLE1 bottle2022-09-120000-00-00NoNoCurrent