FDA.reportPublic FDA data

Nystatin

Product NDC
62135-813
11-digit product format
621350813
Labeler code
62135
Product ID
62135-813_4c47b825-6b93-307f-e063-6394a90a2b7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
NDA050299
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1971-04-14
Substance
NYSTATIN
Active strength
100000 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
N050299-001NILSTATNYSTATIN100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALAARLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050299-001AA

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 22:54:322026-06N050299-001NILSTAT100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALAARLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N050299-001AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINChartwell RX, LLC9954118e-abe6-4388-98c9-4473d39b2e282026-03-05Adverse reactionsExact identifier
application applno (NDA): 050299
application number: NDA050299
ndc (product): 62135-813
NystatinNYSTATINChartwell Governmental & Specialty RX, LLC88a0a22e-8d6b-42aa-b225-2d57fb5b3a972025-11-12Adverse reactionsExact identifier
application applno (NDA): 050299
application number: NDA050299

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 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
9954118e-abe6-4388-98c9-4473d39b2e28Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-813-46Nystatin60 mL in 1 BOTTLESUSPENSION607
62135-813-47Nystatin473 mL in 1 BOTTLESUSPENSION4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-813-05ML - Milliliter62135-813fe55caaf-54d5-488e-9fab-cf7d96fdb8fa12024-12-10
62135-813-24ML - Milliliter62135-813e94dc51c-459e-4f1d-9486-c9ca3a43704412024-12-10
62135-813-46ML - Milliliter62135-81362fd1cad-1d78-46dc-ba8a-004db1afc17112024-08-12
62135-813-47ML - Milliliter62135-813831c03c6-b8d6-49bb-84d2-af8f3052a05412024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-813NYSTATIN SUSPENSION [CHARTWELL RX, LLC]5Current NDC, 2 package rows20250327_9954118e-abe6-4388-98c9-4473d39b2e28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN9954118e-abe6-4388-98c9-4473d39b2e287
312055nystatin 100000 UNT/ML Oral SuspensionSCD9954118e-abe6-4388-98c9-4473d39b2e287
312055nystatin 100,000 UNT/ML Oral SuspensionSY9954118e-abe6-4388-98c9-4473d39b2e287
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY9954118e-abe6-4388-98c9-4473d39b2e287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-813-466213508134660 mL in 1 BOTTLE (62135-813-46) 60 ml2024-06-27NoNoCurrent
62135-813-4762135081347473 mL in 1 BOTTLE (62135-813-47) 473 ml2024-04-10NoNoCurrent