FDA.reportPublic FDA data

NYSTATIN

Product NDC
68071-3543
11-digit product format
680713543
Labeler code
68071
Product ID
68071-3543_2ad1d4c2-cbc9-0304-e063-6394a90aae6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
2026-12-31
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
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
ndc (product): 68071-3543
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
2026-12-31

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
0b4dfd5e-641e-40e9-e063-6294a90a3fdaAvailable 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
68071-3543-6NYSTATIN60 mL in 1 BOTTLESUSPENSION602
68071-3543-6NYSTATIN1 in 1 PACKAGESUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3543NYSTATIN SUSPENSION [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20250105_0b4dfd5e-641e-40e9-e063-6294a90a3fda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN0b4dfd5e-641e-40e9-e063-6294a90a3fda2
312055nystatin 100000 UNT/ML Oral SuspensionSCD0b4dfd5e-641e-40e9-e063-6294a90a3fda2
312055nystatin 100,000 UNT/ML Oral SuspensionSY0b4dfd5e-641e-40e9-e063-6294a90a3fda2
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY0b4dfd5e-641e-40e9-e063-6294a90a3fda2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3543-6680713543061 BOTTLE in 1 PACKAGE (68071-3543-6) / 60 mL in 1 BOTTLE1 bottle2023-11-29NoNoCurrent