NDC 68180-954

HYDROCORTISONE VALERATE

Hydrocortisone Valerate

HYDROCORTISONE VALERATE is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Hydrocortisone Valerate.

• Product ID: 68180-954_7b162949-cd57-4f50-91ce-170c555d5e79
• NDC: 68180-954
• Product Type: Human Prescription Drug
• Proprietary Name: HYDROCORTISONE VALERATE
• Generic Name: Hydrocortisone Valerate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-11-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210307
• Labeler Name: Lupin 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 68180-954-01

1 TUBE in 1 CARTON (68180-954-01) > 15 g in 1 TUBE

• Marketing Start Date: 2019-11-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68180-954-01 [68180095401]

HYDROCORTISONE VALERATE CREAM

• Marketing Category: ANDA
• Application Number: ANDA210307
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-11-19

NDC 68180-954-02 [68180095402]

HYDROCORTISONE VALERATE CREAM

• Marketing Category: ANDA
• Application Number: ANDA210307
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-11-19

NDC 68180-954-03 [68180095403]

HYDROCORTISONE VALERATE CREAM

• Marketing Category: ANDA
• Application Number: ANDA210307
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-11-19

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE VALERATE	2 mg/g

OpenFDA Data

• SPL SET ID: 17e93b8c-aede-4cab-9a8c-0c29abdb05f2
• Manufacturer:
  • Lupin Pharmaceuticals, Inc.
• UNII:
  • 68717P8FUZ
• RxNorm Concept Unique ID - RxCUI:
  • 1370754

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