NDC 55513-137

Otezla

Apremilast

Otezla is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Apremilast.

• Product ID: 55513-137_10ac0969-71a1-4429-924e-f638d552f7b9
• NDC: 55513-137
• Product Type: Human Prescription Drug
• Proprietary Name: Otezla
• Generic Name: Apremilast
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2020-02-26
• Marketing Category: NDA / NDA
• Application Number: NDA205437
• Labeler Name: Amgen Inc
• 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 55513-137-28

1 BLISTER PACK in 1 CARTON (55513-137-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2020-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-137-28 [55513013728]

Otezla TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205437
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-02-26

NDC 55513-137-60 [55513013760]

Otezla TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205437
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-02-26

Drug Details

Active Ingredients

Ingredient	Strength
APREMILAST	30 mg/1

OpenFDA Data

• SPL SET ID: f6b1f516-4972-4d82-bced-113e47b41cc5
• Manufacturer:
  • Amgen Inc
• UNII:
  • UP7QBP99PN
• RxNorm Concept Unique ID - RxCUI:
  • 1605454
  • 1605455
  • 1492747
  • 1492746
  • 1492732
  • 1492744
  • 1492742
  • 1492740
  • 1492738
  • 1492748
• UPC Code:
  • 0355513137607

Pharmacological Class

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

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