NYSTATIN

Product NDC
70771-1585
11-digit product format
707711585
Labeler code
70771
Product ID
70771-1585_ea55d8af-28a2-491e-8aae-aa5102c228aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Zydus Lifesciences Limited
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
70771-1585-1NYSTATIN15 g in 1 BOTTLE, PLASTICPOWDER155
70771-1585-2NYSTATIN30 g in 1 BOTTLE, PLASTICPOWDER305
70771-1585-3NYSTATIN60 g in 1 BOTTLE, PLASTICPOWDER605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1585NYSTATIN POWDER [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 3 package rows20241206_5d593aa9-f2e4-4adf-9f02-37832ffcb5b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSN5d593aa9-f2e4-4adf-9f02-37832ffcb5b45
646456nystatin 100 UNT/MG Topical PowderSCD5d593aa9-f2e4-4adf-9f02-37832ffcb5b45
646456nystatin 100,000 UNT/GM Topical PowderSY5d593aa9-f2e4-4adf-9f02-37832ffcb5b45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1585-17077115850115 g in 1 BOTTLE, PLASTIC (70771-1585-1) 15 g2021-10-060000-00-00NoNoCurrent
70771-1585-27077115850230 g in 1 BOTTLE, PLASTIC (70771-1585-2) 30 g2021-10-060000-00-00NoNoCurrent
70771-1585-37077115850360 g in 1 BOTTLE, PLASTIC (70771-1585-3) 60 g2021-10-060000-00-00NoNoCurrent