FDA.reportPublic FDA data

NYSTATIN

Product NDC
75834-235
Requested package NDC
75834-235-60
11-digit product format
758340235
Labeler code
75834
Product ID
75834-235_f3a36e96-d16e-4c87-903d-b7f797d9c204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA062832
Marketing category
ANDA
Marketing start
2020-08-14
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage75834-23575834-235-60IInactivated by FDA2026-07-31

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
A062832-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1991-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062832-001AA

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 22:54:322026-06A062832-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1991-12-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062832-001AA1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATINNYSTATINKesin Pharma Corporation50737729-a4a4-e747-e063-6394a90adcc52026-06-30Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINBryant Ranch Prepack4f6f59fb-ae7d-48e5-b23e-a1d92160974f2026-05-11Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINKesin Pharma Corporation43817169-bbe8-58ee-e063-6294a90a12502025-12-11Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINKanchan Healthcare Inc90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a2025-09-12Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINBryant Ranch Prepackb06c65cd-5b65-4bc6-aae9-b9381c6f19482023-01-26Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-235-162024-01-30C16284748780-1d6a99b39-95e6-a426-e053-dadaa90af4c2NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-602024-01-30C16284748780-1d6a99b39-95e6-a426-e053-dadaa90af4c2NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-162022-02-16C16284748780-1d6a99b39-95e6-a426-e053-dadaa90af4c2NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-602022-02-16C16284748780-1d6a99b39-95e6-a426-e053-dadaa90af4c2NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-162022-01-28C16284748780-1d6a99b39-95e6-a426-e053-dadaa90af4c2NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-602022-01-28C16284748780-1d6a99b39-95e6-a426-e053-dadaa90af4c2NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-235-16NYSTATIN473 mL in 1 BOTTLESUSPENSION4732
75834-235-60NYSTATIN1 in 1 CARTONSUSPENSION12
75834-235-60NYSTATIN60 mL in 1 BOTTLE, DROPPERSUSPENSION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-235NYSTATIN SUSPENSION [NIVAGEN PHARMACEUTICALS, INC.]2Legacy NDC, 3 package rows20220217_dddbaf12-ecb1-4bd2-8a15-2f75578a8d8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNb06c65cd-5b65-4bc6-aae9-b9381c6f1948103
312055nystatin 100000 UNT/ML Oral SuspensionSCDb06c65cd-5b65-4bc6-aae9-b9381c6f1948103
312055nystatin 100,000 UNT/ML Oral SuspensionSYb06c65cd-5b65-4bc6-aae9-b9381c6f1948103
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYb06c65cd-5b65-4bc6-aae9-b9381c6f1948103
312055nystatin 100,000 UNT/mL Oral SuspensionPSNdddbaf12-ecb1-4bd2-8a15-2f75578a8d8d2
312055nystatin 100000 UNT/ML Oral SuspensionSCDdddbaf12-ecb1-4bd2-8a15-2f75578a8d8d2
312055nystatin 100,000 UNT/ML Oral SuspensionSYdddbaf12-ecb1-4bd2-8a15-2f75578a8d8d2
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYdddbaf12-ecb1-4bd2-8a15-2f75578a8d8d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75834-235-60758340235601 BOTTLE, DROPPER in 1 CARTON (75834-235-60) > 60 mL in 1 BOTTLE, DROPPER2020-08-140000-00-00NoNoCurrent