Nystatin

Product NDC
17856-0811
11-digit product format
178560811
Labeler code
17856
Product ID
17856-0811_964869a5-8615-4c0d-9051-8a90a1270b88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA203621
Marketing category
ANDA
Marketing start
2019-05-07
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0811-1Nystatin0.5 mL in 1 SYRINGESUSPENSION0.53
17856-0811-1Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-2Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-2Nystatin1 mL in 1 SYRINGESUSPENSION13
17856-0811-3Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-3Nystatin2 mL in 1 SYRINGESUSPENSION23
17856-0811-4Nystatin48 in 1 BOX, UNIT-DOSESUSPENSION483
17856-0811-4Nystatin5 mL in 1 SYRINGESUSPENSION53
17856-0811-5Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION53
17856-0811-5Nystatin72 in 1 BOX, UNIT-DOSESUSPENSION723
17856-0811-6Nystatin1 mL in 1 SYRINGESUSPENSION13
17856-0811-6Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-7Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-7Nystatin2 mL in 1 SYRINGESUSPENSION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0811NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 14 package rows20210128_378c70ef-0fbc-4f0d-89c6-200735282fd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 100000 UNT/ML Oral SuspensionSCD378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 100,000 UNT/ML Oral SuspensionSY378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY378c70ef-0fbc-4f0d-89c6-200735282fd73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0811-117856081101120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-1) > .5 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-217856081102120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-2) > 1 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-317856081103120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-3) > 2 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-41785608110448 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-4) > 5 mL in 1 SYRINGE48 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-51785608110572 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0811-5) > 5 mL in 1 CUP, UNIT-DOSE2021-01-260000-00-00NoNoCurrent
17856-0811-617856081106120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-6) > 1 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-717856081107120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-7) > 2 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent