Nystatin

Product NDC
68788-8234
11-digit product format
687888234
Labeler code
68788
Product ID
68788-8234_f0fad244-2407-497b-bc69-10b9c2b7e4d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA061966
Marketing category
ANDA
Marketing start
2022-08-09
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
68788-8234-1GM - Gram68788-82349e4c4086-89b4-4a51-bbaa-6c30b5d5d91812022-09-12
68788-8234-3GM - Gram68788-8234e2bf6fcc-cb5a-46d4-952d-cbe192bd204d12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8234NYSTATIN (NYSTATIN CREAM) CREAM [PREFERRED PHARMACEUTICALS, INC.]3Legacy NDC20240725_f0fad244-2407-497b-bc69-10b9c2b7e4d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8234-1687888234011 TUBE in 1 CARTON (68788-8234-1) > 15 g in 1 TUBE1 tube2022-08-090000-00-00NoNoCurrent
68788-8234-3687888234031 TUBE in 1 CARTON (68788-8234-3) > 30 g in 1 TUBE1 tube2022-08-090000-00-00NoNoCurrent