Nystatin

Product NDC
0121-4785
11-digit product format
001214785
Labeler code
0121
Product ID
0121-4785_7f6f191e-0969-4d20-8189-e65fb74bad39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA062512
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4785-05ML - Milliliter0121-4785be5f9550-3635-48dd-b484-720e77e8364112012-07-24
0121-4785-35ML - Milliliter0121-4785a07ca8a0-e8e8-4977-93e0-0826c7e1dbef12014-01-04