NDC 0713-0669

Hydrocortisone Valerate

Hydrocortisone Valerate

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

• Product ID: 0713-0669_cb58bae6-095d-441d-9dcf-f6d8975fd267
• NDC: 0713-0669
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocortisone Valerate
• Generic Name: Hydrocortisone Valerate
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 1998-08-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075043
• Labeler Name: Cosette Pharmaceuticals, Inc.
• 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 0713-0669-15

1 TUBE in 1 CARTON (0713-0669-15) > 15 g in 1 TUBE

• Marketing Start Date: 2016-01-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0713-0669-37 [00713066937]

Hydrocortisone Valerate OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA075043
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-01-19

NDC 0713-0669-15 [00713066915]

Hydrocortisone Valerate OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA075043
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-01-19

NDC 0713-0669-60 [00713066960]

Hydrocortisone Valerate OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA075043
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-01-19

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE VALERATE	2 mg/g

OpenFDA Data

• SPL SET ID: 767df368-82fc-40ec-8faf-e6a3435c55b3
• Manufacturer:
  • G&W Laboratories, Inc.
• UNII:
  • 68717P8FUZ
• RxNorm Concept Unique ID - RxCUI:
  • 1370750

Pharmacological Class

• 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