Nystatin

Product NDC
63739-160
11-digit product format
637390160
Labeler code
63739
Product ID
63739-160_e26d507e-f7ba-2c85-e053-2995a90a5482
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
McKesson Corporation dba as SKY Packaging
Application
ANDA203621
Marketing category
ANDA
Marketing start
2020-07-17
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63739-160-10Nystatin10 in 1 CASESUSPENSION103
63739-160-10Nystatin10 in 1 TRAYSUSPENSION103
63739-160-70Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-160-10ML - Milliliter63739-1603d56a2ea-3cc6-400b-826c-11189a6305cc12022-08-04
63739-160-56ML - Milliliter63739-1608740c911-dea7-4f53-a608-94da97b130cf12024-03-12
63739-160-70ML - Milliliter63739-160b594c479-4194-4d66-98d6-416e7790ea9612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-160NYSTATIN SUSPENSION [MCKESSON CORPORATION DBA SKY PACKAGING]8Legacy NDC20250406_eb34e6dc-9459-41ac-ae10-78650284b2bc.zip
63739-160NYSTATIN SUSPENSION [MCKESSON CORPORATION DBA AS SKY PACKAGING]3Legacy NDC, 3 package rows20220628_eea6a08a-f796-4afe-88a4-31e5080a2f75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNeea6a08a-f796-4afe-88a4-31e5080a2f753
312055nystatin 100000 UNT/ML Oral SuspensionSCDeea6a08a-f796-4afe-88a4-31e5080a2f753
312055nystatin 100,000 UNT/ML Oral SuspensionSYeea6a08a-f796-4afe-88a4-31e5080a2f753
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYeea6a08a-f796-4afe-88a4-31e5080a2f753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-160-106373901601010 TRAY in 1 CASE (63739-160-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (63739-160-70) 10 tray2022-07-010000-00-00NoNoCurrent
63739-160-70637390160705 mL in 1 CUP, UNIT-DOSE5 mlHistorical