Nystatin

Product NDC
68788-7949
11-digit product format
687887949
Labeler code
68788
Product ID
68788-7949_33f2203b-39c0-4416-a4f3-c2d5a583b911
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA064022
Marketing category
ANDA
Marketing start
2021-07-08
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7949-1GM - Gram68788-7949490ff946-494d-4d1b-90f6-951414109d5b12021-08-05
68788-7949-3GM - Gram68788-79497893ccb9-42aa-4c9e-9c33-eba32d80c33412021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7949NYSTATIN CREAM [PREFERRED PHARMACEUTICALS INC.]4Legacy NDC20240725_072c41d8-190a-425a-8427-bdccaef7527b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7949-1687887949011 TUBE in 1 CARTON (68788-7949-1) > 15 g in 1 TUBE1 tube2021-07-080000-00-00NoNoCurrent
68788-7949-3687887949031 TUBE in 1 CARTON (68788-7949-3) > 30 g in 1 TUBE1 tube2021-07-080000-00-00NoNoCurrent