Nystatin

Product NDC
70518-3284
11-digit product format
705183284
Labeler code
70518
Product ID
70518-3284_d2a9e51a-0f13-6f7f-e053-2a95a90a705c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
REMEDYREPACK INC.
Application
ANDA062225
Marketing category
ANDA
Marketing start
2021-12-08
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3284-02023-03-23C16284748780-1f386c649-b7ef-0266-e053-dadaa90a7c1a629d2b7e-a5b8-4b6d-ba59-46e1c51da5bf
70518-3284-02023-01-30C16284748780-1f386c649-b7ef-0266-e053-dadaa90a7c1a629d2b7e-a5b8-4b6d-ba59-46e1c51da5bf

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3284-0705183284001 TUBE in 1 CARTON (70518-3284-0) > 30 g in 1 TUBE1 tube2021-12-080000-00-00NoNoCurrent