FDA.reportPublic FDA data

NYSTATIN

Product NDC
69315-504
11-digit product format
693150504
Labeler code
69315
Product ID
69315-504_eb4efca9-e5e8-4509-9437-6ad7c593a9ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA214346
Marketing category
ANDA
Marketing start
2022-12-05
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
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]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui312055

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-504-47NYSTATIN473 mL in 1 BOTTLESUSPENSION4735
69315-504-60NYSTATIN60 mL in 1 BOTTLESUSPENSION605
69315-504-60NYSTATIN1 in 1 PACKAGESUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-504-47ML - Milliliter69315-5047ee88db7-6fae-40eb-86e6-51df053fd4fa12023-01-09
69315-504-60ML - Milliliter69315-5049e804b7e-9bfd-4abc-b5b2-d6e7fc37fe1812023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-504NYSTATIN SUSPENSION [LEADING PHARMA, LLC]5Current NDC, Legacy NDC, 3 package rows20241129_954205d8-47ba-4c89-95cd-f0066a514cf9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN954205d8-47ba-4c89-95cd-f0066a514cf95
312055nystatin 100000 UNT/ML Oral SuspensionSCD954205d8-47ba-4c89-95cd-f0066a514cf95
312055nystatin 100,000 UNT/ML Oral SuspensionSY954205d8-47ba-4c89-95cd-f0066a514cf95
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY954205d8-47ba-4c89-95cd-f0066a514cf95
312055nystatin 100,000 UNT/mL Oral SuspensionPSN5c08148f-83e5-4f14-b0d3-af8d2c26062e3
312055nystatin 100000 UNT/ML Oral SuspensionSCD5c08148f-83e5-4f14-b0d3-af8d2c26062e3
312055nystatin 100,000 UNT/ML Oral SuspensionSY5c08148f-83e5-4f14-b0d3-af8d2c26062e3
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY5c08148f-83e5-4f14-b0d3-af8d2c26062e3
312055nystatin 100,000 UNT/mL Oral SuspensionPSN0b4dfd5e-641e-40e9-e063-6294a90a3fda2
312055nystatin 100,000 UNT/mL Oral SuspensionPSN8211a0ef-98a8-4136-986c-23c306db11592
312055nystatin 100000 UNT/ML Oral SuspensionSCD8211a0ef-98a8-4136-986c-23c306db11592
312055nystatin 100000 UNT/ML Oral SuspensionSCD0b4dfd5e-641e-40e9-e063-6294a90a3fda2
312055nystatin 100,000 UNT/ML Oral SuspensionSY8211a0ef-98a8-4136-986c-23c306db11592
312055nystatin 100,000 UNT/ML Oral SuspensionSY0b4dfd5e-641e-40e9-e063-6294a90a3fda2
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY0b4dfd5e-641e-40e9-e063-6294a90a3fda2
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY8211a0ef-98a8-4136-986c-23c306db11592
312055nystatin 100,000 UNT/mL Oral SuspensionPSN8a28274b-8165-4cf5-aae5-51fbf82159161
312055nystatin 100000 UNT/ML Oral SuspensionSCD8a28274b-8165-4cf5-aae5-51fbf82159161
312055nystatin 100,000 UNT/ML Oral SuspensionSY8a28274b-8165-4cf5-aae5-51fbf82159161
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY8a28274b-8165-4cf5-aae5-51fbf82159161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-504-4769315050447473 mL in 1 BOTTLE (69315-504-47) 473 ml2022-12-050000-00-00NoNoCurrent
69315-504-60693150504601 BOTTLE in 1 PACKAGE (69315-504-60) / 60 mL in 1 BOTTLE1 bottle2022-12-050000-00-00NoNoCurrent