FDA.reportPublic FDA data

NYSTATIN

Product NDC
68382-370
11-digit product format
683820370
Labeler code
68382
Product ID
68382-370_7f7aaf27-0265-40b9-a900-341232347fad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208581
Marketing category
ANDA
Marketing start
2021-10-06
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NYSTATIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui646456

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-370-01NYSTATIN15 g in 1 BOTTLE, PLASTICPOWDER158
68382-370-02NYSTATIN30 g in 1 BOTTLE, PLASTICPOWDER308
68382-370-03NYSTATIN60 g in 1 BOTTLE, PLASTICPOWDER608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-370-01GM - Gram68382-370c78712f1-8eae-4465-9717-7459ce24ab6812021-12-08
68382-370-02GM - Gram68382-37012a7d946-1c0e-403e-b05c-77d963c0c9ea12021-12-08
68382-370-03GM - Gram68382-370a2e31e58-4c78-42f9-a996-2bb02dbcd33a12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-370NYSTATIN POWDER [ZYDUS PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 3 package rows20231110_2daf159d-6a12-4b5d-97b3-8069c17e7635.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSN2daf159d-6a12-4b5d-97b3-8069c17e76358
646456nystatin 100 UNT/MG Topical PowderSCD2daf159d-6a12-4b5d-97b3-8069c17e76358
646456nystatin 100,000 UNT/GM Topical PowderSY2daf159d-6a12-4b5d-97b3-8069c17e76358
646456nystatin 100,000 UNT/GM Topical PowderPSNd5f4c2d8-a637-4396-e053-2995a90a600f1
646456nystatin 100 UNT/MG Topical PowderSCDd5f4c2d8-a637-4396-e053-2995a90a600f1
646456nystatin 100,000 UNT/GM Topical PowderSYd5f4c2d8-a637-4396-e053-2995a90a600f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-370-016838203700115 g in 1 BOTTLE, PLASTIC (68382-370-01) 15 g2021-10-060000-00-00NoNoCurrent
68382-370-026838203700230 g in 1 BOTTLE, PLASTIC (68382-370-02) 30 g2021-10-060000-00-00NoNoCurrent
68382-370-036838203700360 g in 1 BOTTLE, PLASTIC (68382-370-03) 60 g2021-10-060000-00-00NoNoCurrent