FDA.reportPublic FDA data

Nystatin

Product NDC
0121-4810
11-digit product format
001214810
Labeler code
0121
Product ID
0121-4810_d57cde69-0eb9-180d-e053-2995a90a33aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA203621
Marketing category
ANDA
Marketing start
2016-02-01
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
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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
0121-4810-00Nystatin10 in 1 TRAYSUSPENSION109
0121-4810-00Nystatin10 in 1 CASESUSPENSION109
0121-4810-05Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION59
0121-4810-40Nystatin10 in 1 TRAYSUSPENSION109
0121-4810-40Nystatin4 in 1 CASESUSPENSION49
0121-4810-50Nystatin5 in 1 CASESUSPENSION59
0121-4810-50Nystatin10 in 1 PACKAGESUSPENSION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4810NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]9Current NDC, Legacy NDC, 7 package rows20220114_31e3da10-5a7b-4bc5-8a4f-3e786b64c13a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN31e3da10-5a7b-4bc5-8a4f-3e786b64c13a9
312055nystatin 100000 UNT/ML Oral SuspensionSCD31e3da10-5a7b-4bc5-8a4f-3e786b64c13a9
312055nystatin 100,000 UNT/ML Oral SuspensionSY31e3da10-5a7b-4bc5-8a4f-3e786b64c13a9
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY31e3da10-5a7b-4bc5-8a4f-3e786b64c13a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-4810-000012148100010 TRAY in 1 CASE (0121-4810-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE10 tray2016-02-010000-00-00NoNoCurrent
0121-4810-05001214810055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-4810-40001214810404 TRAY in 1 CASE (0121-4810-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4810-05) 4 tray2016-02-010000-00-00NoNoCurrent
0121-4810-50001214810505 PACKAGE in 1 CASE (0121-4810-50) / 10 CUP, UNIT-DOSE in 1 PACKAGE / 5 mL in 1 CUP, UNIT-DOSE5 package2020-06-260000-00-00NoNoCurrent