FDA.reportPublic FDA data

Nystatin

Product NDC
39822-3015
Requested package NDC
39822-3015-1
11-digit product format
398223015
Labeler code
39822
Product ID
39822-3015_eedc4d46-9206-09f1-e053-2995a90aecf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA065175
Marketing category
ANDA
Marketing start
2004-08-30
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
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 packagepackage39822-301539822-3015-1DDiscontinued by firm2026-07-31

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
A065175-001NYSTATINNYSTATIN100,000 UNITS/GMPOWDER / TOPICAL2004-12-17

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 22:54:322026-06A065175-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICAL2004-12-17a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
39822-3015-12024-01-30C16284748780-11030e365-15e3-111a-e063-dadaa90a10e2Rx Only. Nystatin Topical Powder, USP FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
39822-3015-32024-01-30C16284748780-11030e365-15e3-111a-e063-dadaa90a10e2Rx Only. Nystatin Topical Powder, USP FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
39822-3015-62024-01-30C16284748780-11030e365-15e3-111a-e063-dadaa90a10e2Rx Only. Nystatin Topical Powder, USP FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-3015-1GM - Gram39822-3015027aace4-566e-4a88-82da-c81a9141ea8412014-10-03
39822-3015-3GM - Gram39822-3015792a1891-6096-4d1a-a49e-6824c207866a12014-10-03
39822-3015-6GM - Gram39822-30152698b1af-3b60-4503-8459-18c5afc04ef712014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN POWDER [X-GEN PHARMACEUTICALS, INC.]7
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN POWDER [X-GEN PHARMACEUTICALS, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UNYSTATIN POWDER [X-GEN PHARMACEUTICALS, INC.]7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-3015-13982230150115 g in 1 BOTTLE, PLASTIC (39822-3015-1) 15 g2004-08-300000-00-00NoNoCurrent