Sulconazole Nitrate

Product NDC
72143-321
11-digit product format
721430321
Labeler code
72143
Product ID
72143-321_fc60cb89-7eba-463c-91b9-1b21cd8637a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulconazole Nitrate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
JG Pharma Inc.
Application
NDA018738
Marketing category
NDA
Marketing start
2020-02-24
Marketing end
2028-10-31
Substance
SULCONAZOLE 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
Sulconazole Nitrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULCONAZOLE NITRATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1T89100D5U

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
312a1339-2d03-1da9-f090-a47730c5330aProduct name120140508
a4a028cc-e548-445b-8dc3-ebf42e7603dbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72143-321-30Sulconazole Nitrate30 mL in 1 BOTTLESOLUTION301
72143-321-30Sulconazole Nitrate1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72143-321-30ML - Milliliter72143-321652750ac-369b-4cc5-acf8-a7994f6cf77612021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72143-321SULCONAZOLE NITRATE SOLUTION [JG PHARMA INC.]1Current NDC, Legacy NDC, 2 package rows20210119_cf6f4340-940c-4a61-b675-456e3297d810.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313125sulconazole nitrate 1 % Topical SolutionPSNcf6f4340-940c-4a61-b675-456e3297d8101
313125sulconazole nitrate 10 MG/ML Topical SolutionSCDcf6f4340-940c-4a61-b675-456e3297d8101
313125sulconazole nitrate 1 % Topical SolutionSYcf6f4340-940c-4a61-b675-456e3297d8101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72143-321-30721430321301 BOTTLE in 1 CARTON (72143-321-30) / 30 mL in 1 BOTTLE1 bottle2020-02-240000-00-00NoNoCurrent