NDC 57893-302

Vytone

Hydrocortisone Acetate, Iodoquinol

Vytone is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Artesa Labs, Llc. The primary component is Hydrocortisone Acetate; Iodoquinol.

• Product ID: 57893-302_60c85e6b-e5b1-09c2-e053-2a91aa0a9460
• NDC: 57893-302
• Product Type: Human Prescription Drug
• Proprietary Name: Vytone
• Generic Name: Hydrocortisone Acetate, Iodoquinol
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-07-29
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Artesa Labs, LLC
• Substance Name: HYDROCORTISONE ACETATE; IODOQUINOL
• Active Ingredient Strength: 19 mg/g; mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57893-302-10

10 PACKET in 1 CARTON (57893-302-10) > 2 g in 1 PACKET (57893-302-01)

• Marketing Start Date: 2011-07-29
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 57893-302-01 [57893030201]

Vytone CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-07-29

NDC 57893-302-10 [57893030210]

Vytone CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-07-29

NDC 57893-302-30 [57893030230]

Vytone CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-07-29

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE ACETATE	19 mg/g

OpenFDA Data

• SPL SET ID: 3d7278ee-2c8e-4df1-9372-d43403122945
• Manufacturer:
  • Artesa Labs, LLC
• UNII:
  • 3X7931PO74
  • 63W7IE88K8
• RxNorm Concept Unique ID - RxCUI:
  • 1436947
  • 1436949

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Vytone" or generic name "Hydrocortisone Acetate, Iodoquinol"

NDC	Brand Name	Generic Name
44118-704	Vytone	HYDROCORTISONE ACETATE, IODOQUINOL
57893-302	Vytone	HYDROCORTISONE ACETATE, IODOQUINOL
52187-551	Hydrocortisone Acetate, Iodoquinol	Hydrocortisone Acetate, Iodoquinol
52191-352	Hydrocortisone Acetate, Iodoquinol	Hydrocortisone Acetate, Iodoquinol