FDA.reportPublic FDA data

Nystatin

Product NDC
21695-643
11-digit product format
216950643
Labeler code
21695
Product ID
21695-643_29ccf947-91c1-405a-aba6-5889e3c75d70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA065148
Marketing category
ANDA
Marketing start
2005-06-28
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-643IInactivated by FDA2026-07-31
excluded packagepackage21695-64321695-643-60IInactivated 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
A065148-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2005-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065148-001AA

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 22:54:322026-06A065148-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2005-06-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065148-001AA1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATINNYSTATINGenus Lifesciences Inc.b25cbae5-eaf5-4501-b013-02c778ca4a4e2026-05-07Adverse reactionsExact identifier
application applno (ANDA): 065148
application number: ANDA065148

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-643-602019-09-24C16284748780-1934fe258-4845-48b1-e053-8cdaa90a720aNYSTATIN ORAL SUSPENSION, USP 100,000 units per mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-643-60Nystatin60 mL in 1 BOTTLE, DROPPERSUSPENSION601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-643-60ML - Milliliter21695-64320738cb3-086c-472e-b196-a47c69fed8bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-643NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_29ccf947-91c1-405a-aba6-5889e3c75d70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN29ccf947-91c1-405a-aba6-5889e3c75d701
312055nystatin 100000 UNT/ML Oral SuspensionSCD29ccf947-91c1-405a-aba6-5889e3c75d701
312055nystatin 100,000 UNT/ML Oral SuspensionSY29ccf947-91c1-405a-aba6-5889e3c75d701
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY29ccf947-91c1-405a-aba6-5889e3c75d701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-643-602169506436060 mL in 1 BOTTLE, DROPPER60 mlHistorical