Home NDC 0168-0054 nystatin
Product NDC 0168-0054
11-digit product format 001680054
Labeler code 0168
Product ID 0168-0054_556fa641-b529-4fdc-882b-82ca44d5f1a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nystatin
Dosage form CREAM
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application ANDA062129
Marketing category ANDA
Marketing start 1979-02-01
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 2021-12-31
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 Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Algeldrate INACTIVE INGREDIENT 03J11K103C NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Ethylenediamine INACTIVE INGREDIENT 60V9STC53F NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 PEG-8 Stearate INACTIVE INGREDIENT 2P9L47VI5E NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Sorbic Acid INACTIVE INGREDIENT X045WJ989B NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Sorbitol INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0168-0054-15 00168005415 1 TUBE in 1 CARTON (0168-0054-15) > 15 g in 1 TUBE 1 tube 1979-02-01 0000-00-00 No No Current 0168-0054-30 00168005430 1 TUBE in 1 CARTON (0168-0054-30) > 30 g in 1 TUBE 1 tube 1979-02-01 0000-00-00 No No Current