NDC 50224-002

Refissa

Tretinoin

Refissa is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Suneva Medical, Inc.. The primary component is Tretinoin.

• Product ID: 50224-002_028f7e8a-ca00-4456-a1d6-b94235741d6c
• NDC: 50224-002
• Product Type: Human Prescription Drug
• Proprietary Name: Refissa
• Generic Name: Tretinoin
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2009-06-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076498
• Labeler Name: Suneva Medical, Inc.
• Substance Name: TRETINOIN
• Active Ingredient Strength: 1 mg/g
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 50224-002-05

40 g in 1 TUBE (50224-002-05)

• Marketing Start Date: 2009-06-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50224-002-04 [50224000204]

REFISSA CREAM

• Marketing Category: ANDA
• Application Number: ANDA076498
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2009-06-17
• Inactivation Date: 2020-01-31

NDC 50224-002-05 [50224000205]

REFISSA CREAM

• Marketing Category: ANDA
• Application Number: ANDA076498
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2009-06-17
• Inactivation Date: 2020-01-31

NDC 50224-002-02 [50224000202]

REFISSA CREAM

• Marketing Category: ANDA
• Application Number: ANDA076498
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-08
• Inactivation Date: 2020-01-31

NDC 50224-002-06 [50224000206]

REFISSA CREAM

• Marketing Category: ANDA
• Application Number: ANDA076498
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2013-01-04
• Inactivation Date: 2020-01-31

NDC 50224-002-03 [50224000203]

REFISSA CREAM

• Marketing Category: ANDA
• Application Number: ANDA076498
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2009-06-17
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TRETINOIN	.5 mg/g

OpenFDA Data

• SPL SET ID: 357ed7c9-6ffa-45b8-94be-4d440f5a1c22
• Manufacturer:
  • Suneva Medical, Inc.
• UNII:
  • 5688UTC01R
• RxNorm Concept Unique ID - RxCUI:
  • 855687
  • 2117659

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]

NDC Crossover Matching brand name "Refissa" or generic name "Tretinoin"

NDC	Brand Name	Generic Name
50224-002	Refissa	Refissa
0187-0005	Altreno	tretinoin
0187-5150	Renova	Tretinoin
0187-5160	Retin-A	Tretinoin
0187-5162	Retin-A	Tretinoin
0187-5164	Retin-A	Tretinoin
0187-5140	Retin-A MICRO	Tretinoin
0187-5144	Retin-A MICRO	Tretinoin
0187-5146	Retin-A MICRO	Tretinoin
0187-5148	Retin-A MICRO	Tretinoin