FDA.reportPublic FDA data

Nystop

Product NDC
72162-1124
11-digit product format
721621124
Labeler code
72162
Product ID
72162-1124_2d351e4f-1d0b-4021-a2b4-b2dd3243702a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA064118
Marketing category
ANDA
Marketing start
1996-08-16
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
Nystop
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui261178, 646456

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72162-1124-2Nystop15 g in 1 BOTTLE, PLASTICPOWDER15102
72162-1124-3Nystop30 g in 1 BOTTLE, PLASTICPOWDER30102
72162-1124-6Nystop60 g in 1 BOTTLE, PLASTICPOWDER60102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1124-2GM - Gram72162-11246c2e216e-b95a-4c12-9b3f-95d5f54d633e12025-02-10
72162-1124-3GM - Gram72162-11245766d1d7-9f4b-4b87-96e3-cc5f211ac88b12025-05-14
72162-1124-6GM - Gram72162-11242f4f50eb-3284-4051-96eb-98c60dee25c412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1124NYSTOP (NYSTATIN) POWDER [BRYANT RANCH PREPACK]101Current NDC, 3 package rows20250406_0bb31239-fb77-442a-a9ee-ba61b45e7e68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSN0bb31239-fb77-442a-a9ee-ba61b45e7e68102
261178NYSTOP 100,000 UNT/GM Topical PowderPSN0bb31239-fb77-442a-a9ee-ba61b45e7e68102
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBD0bb31239-fb77-442a-a9ee-ba61b45e7e68102
646456nystatin 100 UNT/MG Topical PowderSCD0bb31239-fb77-442a-a9ee-ba61b45e7e68102
646456nystatin 100,000 UNT/GM Topical PowderSY0bb31239-fb77-442a-a9ee-ba61b45e7e68102
261178Nystop 100 UNT/MG Topical PowderSY0bb31239-fb77-442a-a9ee-ba61b45e7e68102
261178Nystop 100,000 UNT/GM Topical PowderSY0bb31239-fb77-442a-a9ee-ba61b45e7e68102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1124-27216211240215 g in 1 BOTTLE, PLASTIC (72162-1124-2) 15 g2024-12-24NoNoHistorical
72162-1124-37216211240330 g in 1 BOTTLE, PLASTIC (72162-1124-3) 30 g2024-12-24NoNoHistorical
72162-1124-67216211240660 g in 1 BOTTLE, PLASTIC (72162-1124-6) 60 g2024-12-24NoNoHistorical