FDA.reportPublic FDA data

Nystatin Oral Suspension

Product NDC
0116-4026
11-digit product format
001164026
Labeler code
0116
Product ID
0116-4026_4a2ff89a-52fe-8bf9-e063-6394a90a7f1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA062512
Marketing category
ANDA
Marketing start
2026-02-06
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nystatin Oral Suspension
Listing expiration
2027-12-31

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
0116-4026-05Nystatin Oral Suspension5 mL in 1 CUP, UNIT-DOSESUSPENSION51
0116-4026-11Nystatin Oral Suspension10 in 1 TRAYSUSPENSION101
0116-4026-11Nystatin Oral Suspension10 in 1 CASESUSPENSION101
0116-4026-16Nystatin Oral Suspension473 mL in 1 BOTTLE, PLASTICSUSPENSION4731
0116-4026-50Nystatin Oral Suspension10 in 1 TRAYSUSPENSION101
0116-4026-50Nystatin Oral Suspension5 in 1 CASESUSPENSION51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN4a670371-d373-1ba6-e063-6394a90a13b61
312055nystatin 100000 UNT/ML Oral SuspensionSCD4a670371-d373-1ba6-e063-6394a90a13b61
312055nystatin 100,000 UNT/ML Oral SuspensionSY4a670371-d373-1ba6-e063-6394a90a13b61
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY4a670371-d373-1ba6-e063-6394a90a13b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0116-4026-05001164026055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0116-4026-110011640261110 TRAY in 1 CASE (0116-4026-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05) 10 tray2026-02-06NoNoHistorical
0116-4026-1600116402616473 mL in 1 BOTTLE, PLASTIC (0116-4026-16) 473 ml2026-02-09NoNoHistorical
0116-4026-50001164026505 TRAY in 1 CASE (0116-4026-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05) 5 tray2026-02-09NoNoHistorical