nystatin

Product NDC
0168-0054
11-digit product format
001680054
Labeler code
0168
Product ID
0168-0054_556fa641-b529-4fdc-882b-82ca44d5f1a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA062129
Marketing category
ANDA
Marketing start
1979-02-01
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0054-15GM - Gram0168-005426117686-e6fd-468d-8bb1-b5c7e40c32eb12013-09-04
0168-0054-30GM - Gram0168-00540f9a7c43-5f21-40ff-b45b-38c62802e73c12013-09-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN49699081-83d7-458d-bd6f-ae1fd4b8072c1
543546nystatin 100000 UNT/ML Topical CreamSCD49699081-83d7-458d-bd6f-ae1fd4b8072c1
543546nystatin 100,000 UNT/GM Topical CreamSY49699081-83d7-458d-bd6f-ae1fd4b8072c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0054-15001680054151 TUBE in 1 CARTON (0168-0054-15) > 15 g in 1 TUBE1 tube1979-02-010000-00-00NoNoCurrent
0168-0054-30001680054301 TUBE in 1 CARTON (0168-0054-30) > 30 g in 1 TUBE1 tube1979-02-010000-00-00NoNoCurrent