Nystatin

Product NDC
68382-333
11-digit product format
683820333
Labeler code
68382
Product ID
68382-333_b8112032-9d6b-4cdc-8bc2-827a80ab52fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA207767
Marketing category
ANDA
Marketing start
2018-08-08
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 U/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-333-01GM - Gram68382-333297ebe73-f498-4925-a180-3d92599a74ab12019-11-12
68382-333-02GM - Gram68382-3330a7a0897-c9b5-4250-949e-bd662e54354912019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-333-016838203330115 g in 1 TUBE (68382-333-01) 15 g2018-08-080000-00-00NoNoCurrent
68382-333-026838203330230 g in 1 TUBE (68382-333-02) 30 g2018-08-080000-00-00NoNoCurrent