NDC 68462-836

Hydrocortisone Valerate

Hydrocortisone Valerate

Hydrocortisone Valerate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Hydrocortisone Valerate.

• Product ID: 68462-836_18db91a0-fe67-4740-8a37-d656707356f1
• NDC: 68462-836
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocortisone Valerate
• Generic Name: Hydrocortisone Valerate
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-03-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211750
• Labeler Name: Glenmark Pharmaceuticals Inc., USA
• Substance Name: HYDROCORTISONE VALERATE
• Active Ingredient Strength: 2 mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68462-836-17

1 TUBE in 1 CARTON (68462-836-17) > 15 g in 1 TUBE

• Marketing Start Date: 2019-03-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68462-836-65 [68462083665]

Hydrocortisone Valerate OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA211750
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-03-05

NDC 68462-836-47 [68462083647]

Hydrocortisone Valerate OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA211750
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-03-05

NDC 68462-836-17 [68462083617]

Hydrocortisone Valerate OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA211750
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-03-05

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE VALERATE	2 mg/g

OpenFDA Data

• SPL SET ID: 18db91a0-fe67-4740-8a37-d656707356f1
• Manufacturer:
  • Glenmark Pharmaceuticals Inc., USA
• UNII:
  • 68717P8FUZ
• RxNorm Concept Unique ID - RxCUI:
  • 1370750
• UPC Code:
  • 0368462836477
  • 0368462836170
  • 0368462836651

Pharmacological Class

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

NDC Crossover Matching brand name "Hydrocortisone Valerate" or generic name "Hydrocortisone Valerate"

NDC	Brand Name	Generic Name
0713-0560	Hydrocortisone Valerate	HYDROCORTISONE VALERATE
0713-0668	Hydrocortisone Valerate	Hydrocortisone Valerate
0713-0669	Hydrocortisone Valerate	HYDROCORTISONE VALERATE
0713-0720	HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE
21695-730	Hydrocortisone Valerate	Hydrocortisone Valerate
45802-455	Hydrocortisone Valerate	Hydrocortisone Valerate
50090-2525	Hydrocortisone Valerate	Hydrocortisone Valerate
51672-1290	Hydrocortisone Valerate	Hydrocortisone Valerate
51672-1292	Hydrocortisone Valerate	Hydrocortisone Valerate
61919-010	HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE
68180-954	HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE
68462-575	Hydrocortisone valerate	Hydrocortisone valerate
68462-836	Hydrocortisone Valerate	HYDROCORTISONE VALERATE