NDC 52565-087

Hydrocortisone Butyrate

Hydrocortisone Butyrate

Hydrocortisone Butyrate is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Teligent Pharma, Inc.. The primary component is Hydrocortisone Butyrate.

• Product ID: 52565-087_2fba5a07-187f-4b21-a961-2f567994c50f
• NDC: 52565-087
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocortisone Butyrate
• Generic Name: Hydrocortisone Butyrate
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-11-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209556
• Labeler Name: Teligent Pharma, Inc.
• Substance Name: HYDROCORTISONE BUTYRATE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 52565-087-02

1 BOTTLE in 1 CARTON (52565-087-02) > 59 mL in 1 BOTTLE

• Marketing Start Date: 2017-11-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52565-087-02 [52565008702]

Hydrocortisone Butyrate LOTION

• Marketing Category: ANDA
• Application Number: ANDA209556
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-21

NDC 52565-087-04 [52565008704]

Hydrocortisone Butyrate LOTION

• Marketing Category: ANDA
• Application Number: ANDA209556
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-21

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE BUTYRATE	1 mg/mL

OpenFDA Data

• SPL SET ID: 97d35248-b28b-18b0-98a6-2d93476fb4a3
• Manufacturer:
  • Teligent Pharma, Inc.
• UNII:
  • 05RMF7YPWN
• RxNorm Concept Unique ID - RxCUI:
  • 1370763

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0472-0490	Hydrocortisone Butyrate	Hydrocortisone Butyrate
21695-971	Hydrocortisone Butyrate	Hydrocortisone Butyrate
51672-4061	Hydrocortisone Butyrate	Hydrocortisone Butyrate
51672-4074	Hydrocortisone Butyrate	Hydrocortisone Butyrate
51672-4083	Hydrocortisone Butyrate	Hydrocortisone Butyrate
51862-159	HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE
52565-087	Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE
68180-951	Hydrocortisone Butyrate	Hydrocortisone Butyrate
68462-464	Hydrocortisone Butyrate	Hydrocortisone Butyrate
68682-270	HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE
68682-271	Hydrocortisone Butyrate	hydrocortisone butyrate
68682-273	Hydrocortisone Butyrate	hydrocortisone butyrate
68682-384	Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE
68682-392	HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE
68788-7719	Hydrocortisone Butyrate	Hydrocortisone Butyrate Lotion
70512-032	Hydrocortisone Butyrate	Hydrocortisone Butyrate
16781-382	Locoid	HYDROCORTISONE BUTYRATE
16781-391	Locoid	HYDROCORTISONE BUTYRATE
16781-392	Locoid	HYDROCORTISONE BUTYRATE
16781-384	Locoid Lipocream	HYDROCORTISONE BUTYRATE