NDC 59212-601

PANRETIN

Alitretinoin

PANRETIN is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Concordia Pharmaceuticals Inc.. The primary component is Alitretinoin.

• Product ID: 59212-601_1629bcf4-47bc-4203-878f-c7daeb6e8fc7
• NDC: 59212-601
• Product Type: Human Prescription Drug
• Proprietary Name: PANRETIN
• Generic Name: Alitretinoin
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-09-10
• Marketing Category: NDA / NDA
• Application Number: NDA020886
• Labeler Name: Concordia Pharmaceuticals Inc.
• Substance Name: ALITRETINOIN
• Active Ingredient Strength: 60 mg/60g
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 59212-601-22

60 g in 1 TUBE (59212-601-22)

• Marketing Start Date: 2019-09-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59212-601-22 [59212060122]

PANRETIN GEL

• Marketing Category: NDA
• Application Number: NDA020886
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-10

Drug Details

Active Ingredients

Ingredient	Strength
ALITRETINOIN	60 mg/60g

OpenFDA Data

• SPL SET ID: 49c16717-7d86-4257-80c9-baa1417e5555
• Manufacturer:
  • Concordia Pharmaceuticals Inc.
• UNII:
  • 1UA8E65KDZ
• RxNorm Concept Unique ID - RxCUI:
  • 213502
  • 313847
• UPC Code:
  • 0359212601223

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]
• Retinoid [EPC]
• Retinoids [CS]

NDC Crossover Matching brand name "PANRETIN" or generic name "Alitretinoin"

NDC	Brand Name	Generic Name
59212-601	PANRETIN	alitretinoin
62856-601	Panretin	Alitretinoin