Home NDC 68788-9247 nystatin
Product NDC 68788-9247
11-digit product format 687889247
Labeler code 68788
Product ID 68788-9247_f5d79b2a-e2de-4c03-9287-6f99f5f78a7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nystatin
Dosage form CREAM
Route TOPICAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA062129
Marketing category ANDA
Marketing start 2014-11-13
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 2020-12-31
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 A062129-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062129-001 AT
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 A062129-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A062129-001 AT 1 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Algeldrate INACTIVE INGREDIENT 03J11K103C NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Ethylenediamine INACTIVE INGREDIENT 60V9STC53F NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 PEG-8 Stearate INACTIVE INGREDIENT 2P9L47VI5E NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Sorbic Acid INACTIVE INGREDIENT X045WJ989B NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1