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 ID68782-001_48b1952b-3ef6-4437-8592-5f4f4543e370
NDC68782-001
Product TypeHuman Prescription Drug
Proprietary NameMacugen
Generic NamePegaptanib Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAVITREAL
Marketing Start Date2004-12-17
Marketing CategoryNDA / NDA
Application NumberNDA021756
Labeler NameBausch & Lomb Incorporated
Substance NamePEGAPTANIB SODIUM
Active Ingredient Strength3 mg/mL
Pharm ClassesOligonucleotides [CS],Aptamers, Nucleotide [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68782-001-02

1 SYRINGE in 1 CARTON (68782-001-02) > .09 mL in 1 SYRINGE
Marketing Start Date2004-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68782-001-02 [68782000102]

Macugen INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021756
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-12-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PEGAPTANIB SODIUM3.47 mg/mL

OpenFDA Data

SPL SET ID:45d03177-5d52-492c-b2e0-01afc7c8d2e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1011625
  • 1011626
  • Pharmacological Class

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

    Trademark Results [Macugen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MACUGEN
    MACUGEN
    78487900 3140127 Dead/Cancelled
    EYETECH, INC.
    2004-09-22
    MACUGEN
    MACUGEN
    78089303 2907160 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2001-10-19

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.