NDC 10631-095

HALOG

Halcinonide Topical

HALOG is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Halcinonide.

• Product ID: 10631-095_550b8c9f-e5a8-48c4-a3ff-1a56a3caac33
• NDC: 10631-095
• Product Type: Human Prescription Drug
• Proprietary Name: HALOG
• Generic Name: Halcinonide Topical
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-03-18
• Marketing Category: NDA / NDA
• Application Number: NDA017823
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: HALCINONIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 10631-095-10

1 BOTTLE, PLASTIC in 1 CARTON (10631-095-10) > 120 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2020-03-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10631-095-20 [10631009520]

HALOG SOLUTION

• Marketing Category: NDA
• Application Number: NDA017823
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-18

NDC 10631-095-10 [10631009510]

HALOG SOLUTION

• Marketing Category: NDA
• Application Number: NDA017823
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-18

Drug Details

Active Ingredients

Ingredient	Strength
HALCINONIDE	1 mg/mL

OpenFDA Data

• SPL SET ID: 550b8c9f-e5a8-48c4-a3ff-1a56a3caac33
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • SI86V6QNEG
• RxNorm Concept Unique ID - RxCUI:
  • 310669
  • 206550

Pharmacological Class

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

NDC Crossover Matching brand name "HALOG" or generic name "Halcinonide Topical"

NDC	Brand Name	Generic Name
0003-0249	HALOG	Halcinonide
10631-094	Halog	Halcinonide Cream
10631-095	HALOG	Halcinonide Topical
10631-096	HALOG	HALCINONIDE