FDA.reportPublic FDA data

Nystatin

Product NDC
21695-761
11-digit product format
216950761
Labeler code
21695
Product ID
21695-761_fb98a6b8-da0c-40f4-9e53-487b541865b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA064022
Marketing category
ANDA
Marketing start
1993-01-29
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 mg/g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-761IInactivated by FDA2026-08-03
excluded packagepackage21695-76121695-761-15IInactivated by FDA2026-08-03
excluded packagepackage21695-76121695-761-30IInactivated by FDA2026-08-03

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
A064022-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALATRS1993-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064022-001AT

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 22:54:322026-06A064022-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATRS1993-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A064022-001AT1a50c72e98297…

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
NystatinNYSTATINSun Pharmaceutical Industries, Inc.4d845b3f-ca26-4c47-b424-b6d783cc10e52025-07-03Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
NystatinNYSTATINNuCare Pharmaceuticals,Inc.cf6b7c68-7769-1808-e053-2995a90aa4262025-02-10Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
NYSTATINNYSTATINDIRECT RXcd387929-5b72-e3c0-e053-2a95a90adb222025-01-20Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
NystatinNYSTATINNuCare Pharmaceuticals,Inc.57825c04-dcb5-b76d-e053-2991aa0a4c1d2024-08-14Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
NystatinNYSTATINProficient Rx LP5ef15e1c-66dc-4858-8552-d83e42c3883e2019-11-01Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-761-152019-09-24C16284748780-1934fe258-487e-48b1-e053-8cdaa90a720aNystatin Cream USP, 100,000 units per gram
21695-761-302019-09-24C16284748780-1934fe258-487e-48b1-e053-8cdaa90a720aNystatin Cream USP, 100,000 units per gram

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-761-15Nystatin15 g in 1 TUBECREAM151
21695-761-15Nystatin1 in 1 CARTONCREAM11
21695-761-30Nystatin1 in 1 CARTONCREAM11
21695-761-30Nystatin30 g in 1 TUBECREAM301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-761-15GM - Gram21695-761b5aaac98-43a4-4919-9a1e-74408bbaa00812012-07-24
21695-761-30GM - Gram21695-7613246afc3-3809-4ac8-b4ed-6770e5e0b18012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
ALGELDRATEINACTIVE INGREDIENT03J11K103CNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
CETEARETH-12INACTIVE INGREDIENT7V4MR24V5PNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32INYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-761NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20101124_fb98a6b8-da0c-40f4-9e53-487b541865b5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-761-152169507611515 g in 1 TUBE15 gHistorical
21695-761-30216950761301 in 1 CARTONHistorical