Nystatin

Product NDC
17856-1045
11-digit product format
178561045
Labeler code
17856
Product ID
17856-1045_35ceeae7-4f25-4d5a-e063-6394a90a8ff7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA203621
Marketing category
ANDA
Marketing start
2024-06-21
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1045-1Nystatin72 in 1 BOX, UNIT-DOSESUSPENSION723
17856-1045-2Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION53
17856-1045-3Nystatin48 in 1 BOX, UNIT-DOSESUSPENSION483
17856-1045-4Nystatin5 mL in 1 SYRINGESUSPENSION53
17856-1045-5Nystatin48 in 1 BOX, UNIT-DOSESUSPENSION483
17856-1045-6Nystatin5 mL in 1 SYRINGESUSPENSION53
17856-1045-7Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-1045-8Nystatin1 mL in 1 SYRINGESUSPENSION13
17856-1045-9Nystatin5 mL in 1 SYRINGESUSPENSION53
17856-1045-9Nystatin1 in 1 BAGSUSPENSION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1045-1ML - Milliliter17856-104567a16705-3c65-4aa4-8a0a-1e38af699cf112024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1045NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]3Current NDC, 10 package rows20250524_2e7fadda-5f16-4be6-b6bb-985fafe3a1f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN2e7fadda-5f16-4be6-b6bb-985fafe3a1f33
312055nystatin 100000 UNT/ML Oral SuspensionSCD2e7fadda-5f16-4be6-b6bb-985fafe3a1f33
312055nystatin 100,000 UNT/ML Oral SuspensionSY2e7fadda-5f16-4be6-b6bb-985fafe3a1f33
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY2e7fadda-5f16-4be6-b6bb-985fafe3a1f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-1045-11785610450172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1045-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-1045-2) 2024-07-18NoNoHistorical
17856-1045-2178561045025 mL in 1 CUP, UNIT-DOSE5 mlHistorical
17856-1045-31785610450348 SYRINGE in 1 BOX, UNIT-DOSE (17856-1045-3) / 5 mL in 1 SYRINGE (17856-1045-4) 48 syringe2024-07-18NoNoHistorical
17856-1045-4178561045045 mL in 1 SYRINGE5 mlHistorical
17856-1045-51785610450548 SYRINGE in 1 BOX, UNIT-DOSE (17856-1045-5) / 5 mL in 1 SYRINGE (17856-1045-6) 48 syringe2024-07-18NoNoHistorical
17856-1045-6178561045065 mL in 1 SYRINGE5 mlHistorical
17856-1045-717856104507120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1045-7) / 1 mL in 1 SYRINGE (17856-1045-8) 120 syringe2024-07-18NoNoHistorical
17856-1045-8178561045081 mL in 1 SYRINGE1 mlHistorical
17856-1045-9178561045091 SYRINGE in 1 BAG (17856-1045-9) / 5 mL in 1 SYRINGE1 syringe2024-07-18NoNoHistorical