Nystatin

Product NDC
70771-1357
11-digit product format
707711357
Labeler code
70771
Product ID
70771-1357_f94a3196-9f89-4b93-8b26-bf811b9bbc3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207767
Marketing category
ANDA
Marketing start
2018-08-08
Substance
NYSTATIN
Active strength
100000 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 U/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui884308

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
70771-1357-1Nystatin15 g in 1 TUBEOINTMENT155
70771-1357-2Nystatin30 g in 1 TUBEOINTMENT305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1357NYSTATIN OINTMENT [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 2 package rows20240821_6aa2f67e-9636-45e5-be1b-83e7ab86e436.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSN6aa2f67e-9636-45e5-be1b-83e7ab86e4365
884308nystatin 100 UNT/MG Topical OintmentSCD6aa2f67e-9636-45e5-be1b-83e7ab86e4365
884308nystatin 100,000 UNT/GM Topical OintmentSY6aa2f67e-9636-45e5-be1b-83e7ab86e4365

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1357-17077113570115 g in 1 TUBE (70771-1357-1) 15 g2018-08-080000-00-00NoNoCurrent
70771-1357-27077113570230 g in 1 TUBE (70771-1357-2) 30 g2018-08-080000-00-00NoNoCurrent