Home NDC 68258-3046 Nystatin
Product NDC 68258-3046
11-digit product format 682583046
Labeler code 68258
Product ID 68258-3046_74567b8a-65a1-45be-8f6d-12261d9118ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nystatin
Dosage form CREAM
Route TOPICAL
Labeler Dispensing Solutions, Inc.
Application ANDA065315
Marketing category ANDA
Marketing start 2006-05-31
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 100000 [USP'U]/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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065315-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68258-3046-3 Nystatin 30 g in 1 TUBE CREAM 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68258-3046 NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 Legacy NDC, 1 package rows 20111013_377b0312-abfe-45eb-9e6e-ae348ec83325.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 68258-3046-3 68258304603 30 g in 1 TUBE 30 g Historical