FDA.reportPublic FDA data

Nystatin

Product NDC
63187-422
Requested package NDC
63187-422-15
11-digit product format
631870422
Labeler code
63187
Product ID
63187-422_cc949ee7-fc09-4b2f-a26d-bb6a435f75c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA062949
Marketing category
ANDA
Marketing start
2010-07-21
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
2022-12-31
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 packagepackage63187-42263187-422-15DDiscontinued by firm2026-08-03

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
A062949-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALAT1988-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062949-001AT

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 22:54:322026-06A062949-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT1988-06-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062949-001AT1a50c72e98297…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [PROFICIENT RX LP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [PROFICIENT RX LP]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0NYSTATIN CREAM [PROFICIENT RX LP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNYSTATIN CREAM [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNYSTATIN CREAM [PROFICIENT RX LP]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [PROFICIENT RX LP]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9INYSTATIN CREAM [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [PROFICIENT RX LP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [PROFICIENT RX LP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNYSTATIN CREAM [PROFICIENT RX LP]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BNYSTATIN CREAM [PROFICIENT RX LP]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-422NYSTATIN CREAM [PROFICIENT RX LP]3Legacy NDC20210115_b9d5a099-00ef-40b6-90a4-254f2be551d5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-422-15631870422151 TUBE in 1 CARTON (63187-422-15) > 15 g in 1 TUBE1 tube2019-01-010000-00-00NoNoCurrent