NDC 68782-001

Macugen

Pegaptanib Sodium

Macugen is a Intravitreal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is Pegaptanib Sodium.

• Product ID: 68782-001_48b1952b-3ef6-4437-8592-5f4f4543e370
• NDC: 68782-001
• Product Type: Human Prescription Drug
• Proprietary Name: Macugen
• Generic Name: Pegaptanib Sodium
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVITREAL
• Marketing Start Date: 2004-12-17
• Marketing Category: NDA / NDA
• Application Number: NDA021756
• Labeler Name: Bausch & Lomb Incorporated
• Substance Name: PEGAPTANIB SODIUM
• Active Ingredient Strength: 3 mg/mL
• Pharm Classes: Oligonucleotides [CS],Aptamers, Nucleotide [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68782-001-02

1 SYRINGE in 1 CARTON (68782-001-02) > .09 mL in 1 SYRINGE

• Marketing Start Date: 2004-12-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68782-001-02 [68782000102]

Macugen INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021756
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-12-17
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PEGAPTANIB SODIUM	3.47 mg/mL

OpenFDA Data

• SPL SET ID: 45d03177-5d52-492c-b2e0-01afc7c8d2e0
• Manufacturer:
  • Bausch & Lomb Incorporated
• UNII:
  • 3HP012Q0FH
• RxNorm Concept Unique ID - RxCUI:
  • 1011625
  • 1011626

Pharmacological Class

• Oligonucleotides [CS]
• Aptamers
• Nucleotide [CS]