NDC 53113-262

Gadaderm Hydrocortisone

Hydrocortisone Acetate

Gadaderm Hydrocortisone is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Gadal Laboratories Inc. The primary component is Hydrocortisone Acetate.

• Product ID: 53113-262_18d0cac1-584a-4679-8888-65051e73ebbd
• NDC: 53113-262
• Product Type: Human Otc Drug
• Proprietary Name: Gadaderm Hydrocortisone
• Generic Name: Hydrocortisone Acetate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-06-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Gadal Laboratories Inc
• Substance Name: HYDROCORTISONE ACETATE
• Active Ingredient Strength: 1 g/100g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 53113-262-01

1 TUBE in 1 BOX (53113-262-01) > 42.52 g in 1 TUBE

• Marketing Start Date: 2013-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53113-262-01 [53113026201]

Gadaderm Hydrocortisone CREAM

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-06-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE ACETATE	.5 g/100g

OpenFDA Data

• SPL SET ID: 986317c2-5f75-406a-ae13-375d11b21a44
• Manufacturer:
  • Gadal Laboratories Inc
• UNII:
  • 3X7931PO74
• RxNorm Concept Unique ID - RxCUI:
  • 1438754
  • 1250490

NDC Crossover Matching brand name "Gadaderm Hydrocortisone" or generic name "Hydrocortisone Acetate"

NDC	Brand Name	Generic Name
53113-262	Gadaderm Hydrocortisone	Gadaderm Hydrocortisone
0316-0140	Ala Scalp	Hydrocortisone Acetate
0713-0503	ANUCORT-HC	Hydrocortisone Acetate
43474-000	bioCorneum HC Advanced Scar Supervision Anti-Itch	HYDROCORTISONE ACETATE
0037-6830	Cortifoam	hydrocortisone acetate
16477-201	Hemmorex-HC	hydrocortisone acetate
16477-202	Hemmorex-HC	hydrocortisone acetate
0363-0972	Hydrocortisone	Hydrocortisone Acetate
11822-2069	Hydrocortisone	Hydrocortisone Acetate
0574-7090	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
0574-7093	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
0713-0493	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
10135-751	Hydrocortisone Acetate	Hydrocortisone Acetate
16571-676	Hydrocortisone Acetate	Hydrocortisone Acetate
24689-102	Hydrocortisone Acetate	Hydrocortisone Acetate
24689-103	Hydrocortisone Acetate	Hydrocortisone Acetate
39328-029	Hydrocortisone Acetate	Hydrocortisone Acetate
39328-129	Hydrocortisone Acetate	Hydrocortisone Acetate
42494-301	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
42494-302	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
42494-341	Hydrocortisone Acetate	Hydrocortisone Acetate
42494-342	Hydrocortisone Acetate	Hydrocortisone Acetate
47832-205	Hydrocortisone Acetate	Hydrocortisone Acetate
0179-8710	KAISER PERMANENTE	Hydrocortisone acetate
47682-923	Medi-First 1% Hydrocortisone	Hydrocortisone acetate
47682-207	Medi-First Hydrocortisone 1%	Hydrocortisone acetate
15014-185	NuCort	Hydrocortisone Acetate
11509-5101	Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula	Hydrocortisone Acetate