NDC 0006-3026

KEYTRUDA

Pembrolizumab

KEYTRUDA is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Pembrolizumab.

• Product ID: 0006-3026_064f791c-8110-49ad-9d6b-770dec7ccbd5
• NDC: 0006-3026
• Product Type: Human Prescription Drug
• Proprietary Name: KEYTRUDA
• Generic Name: Pembrolizumab
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-01-15
• Marketing Category: BLA / BLA
• Application Number: BLA125514
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: PEMBROLIZUMAB
• Active Ingredient Strength: 25 mg/mL
• Pharm Classes: Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0006-3026-02

1 VIAL in 1 CARTON (0006-3026-02) > 10 mL in 1 VIAL (0006-3026-01)

• Marketing Start Date: 2015-01-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-3026-02 [00006302602]

KEYTRUDA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125514
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-01-15

NDC 0006-3026-04 [00006302604]

KEYTRUDA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125514
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-08-01

NDC 0006-3026-01 [00006302601]

KEYTRUDA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125514
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-01-15

Drug Details

Active Ingredients

Ingredient	Strength
PEMBROLIZUMAB	25 mg/mL

OpenFDA Data

• SPL SET ID: 9333c79b-d487-4538-a9f0-71b91a02b287
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • DPT0O3T46P
• RxNorm Concept Unique ID - RxCUI:
  • 1657746
  • 1657750
  • 1657751
  • 1657749

Pharmacological Class

• Programmed Death Receptor-1 Blocking Antibody [EPC]
• Programmed Death Receptor-1-directed Antibody Interactions [MoA]

NDC Crossover Matching brand name "KEYTRUDA" or generic name "Pembrolizumab"

NDC	Brand Name	Generic Name
0006-3026	KEYTRUDA	pembrolizumab
0006-3029	KEYTRUDA	pembrolizumab