FDA.reportPublic FDA data

NYSTATIN

Product NDC
17856-0508
Requested package NDC
17856-0508-5
11-digit product format
178560508
Labeler code
17856
Product ID
17856-0508_484acdef-5f40-bd3e-e063-6394a90aebe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214346-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS2022-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A214346-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A214346-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS2022-03-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214346-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATINNYSTATINATLANTIC BIOLOGICALS CORP.5c08148f-83e5-4f14-b0d3-af8d2c26062e2026-01-13Adverse reactionsExact identifier
application applno (ANDA): 214346
application number: ANDA214346
ndc (package): 17856-0508-5
ndc (product): 17856-0508
ndc11 (package): 17856050805
NYSTATINNYSTATINPreferred Pharmaceuticals Inc.8211a0ef-98a8-4136-986c-23c306db11592025-08-29Adverse reactionsExact identifier
application applno (ANDA): 214346
application number: ANDA214346
NYSTATINNYSTATINNuCare Pharmaceuticals,Inc.0b4dfd5e-641e-40e9-e063-6294a90a3fda2025-01-03Adverse reactionsExact identifier
application applno (ANDA): 214346
application number: ANDA214346
NYSTATINNYSTATINLeading Pharma, LLC954205d8-47ba-4c89-95cd-f0066a514cf92024-11-28Adverse reactionsExact identifier
application applno (ANDA): 214346
application number: ANDA214346

Additional Listing Data#

Finished product
Yes
Brand name base
NYSTATIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDF1O1C72EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312055Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c08148f-83e5-4f14-b0d3-af8d2c26062eAvailable on FDA.report

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
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
17856-0508-1NYSTATIN5 mL in 1 CUP, UNIT-DOSESUSPENSION53
17856-0508-1NYSTATIN72 in 1 BOX, UNIT-DOSESUSPENSION723
17856-0508-3NYSTATIN5 mL in 1 SYRINGESUSPENSION53
17856-0508-3NYSTATIN48 in 1 BOX, UNIT-DOSESUSPENSION483
17856-0508-5NYSTATIN48 in 1 BOX, UNIT-DOSESUSPENSION483
17856-0508-5NYSTATIN5 mL in 1 SYRINGESUSPENSION53
17856-0508-7NYSTATIN1 mL in 1 SYRINGESUSPENSION13
17856-0508-7NYSTATIN120 in 1 BOX, UNIT-DOSESUSPENSION1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0508-7ML - Milliliter17856-0508088e446d-e273-4df0-9669-405c41d60af512026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0508NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]2Current NDC, 8 package rows20240719_5c08148f-83e5-4f14-b0d3-af8d2c26062e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-0508-51785605080548 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-5) / 5 mL in 1 SYRINGE48 syringe2024-07-17NoNoCurrent