NDC 59572-631

OTEZLA

Apremilast

OTEZLA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Celgene Corporation. The primary component is Apremilast.

• Product ID: 59572-631_4b03ba80-afc7-4904-8c87-ef84b8fd25ea
• NDC: 59572-631
• Product Type: Human Prescription Drug
• Proprietary Name: OTEZLA
• Generic Name: Apremilast
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-04-03
• Marketing Category: NDA / NDA
• Application Number: NDA205437
• Labeler Name: Celgene Corporation
• Substance Name: APREMILAST
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 59572-631-06

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59572-631-06)

• Marketing Start Date: 2015-09-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59572-631-28 [59572063128]

OTEZLA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205437
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-08-05

NDC 59572-631-06 [59572063106]

OTEZLA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205437
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-18

Drug Details

Active Ingredients

Ingredient	Strength
APREMILAST	30 mg/1

OpenFDA Data

• SPL SET ID: 3acf6751-827d-11e2-9e96-0800200c9a66
• Manufacturer:
  • Celgene Corporation
• UNII:
  • UP7QBP99PN
• RxNorm Concept Unique ID - RxCUI:
  • 1605454
  • 1605455
  • 1492747
  • 1492746
  • 1492732
  • 1492744
  • 1492742
  • 1492740
  • 1492738
  • 1492748
• UPC Code:
  • 0359572631991

Pharmacological Class

• Phosphodiesterase 4 Inhibitor [EPC]
• Phosphodiesterase 4 Inhibitors [MoA]

Medicade Reported Pricing

59572063106 OTEZLA 30 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "OTEZLA" or generic name "Apremilast"

NDC	Brand Name	Generic Name
55513-137	Otezla	apremilast
55513-369	Otezla	apremilast
55513-485	Otezla	apremilast
59572-630	OTEZLA	apremilast
59572-631	OTEZLA	apremilast
59572-632	OTEZLA	apremilast
70518-3155	Otezla	apremilast
60219-1410	APREMILAST	APREMILAST
60219-1744	APREMILAST	APREMILAST