NDC 62756-452

BYNFEZIA Pen

Octreotide Acetate

BYNFEZIA Pen is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Octreotide Acetate.

Product ID62756-452_b2b247c5-d78d-4708-bc90-cee97d96f814
NDC62756-452
Product TypeHuman Prescription Drug
Proprietary NameBYNFEZIA Pen
Generic NameOctreotide Acetate
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2020-04-29
Marketing CategoryNDA / NDA
Application NumberNDA213224
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameOCTREOTIDE ACETATE
Active Ingredient Strength3 mg/mL
Pharm ClassesSomatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 62756-452-36

1 CARTRIDGE in 1 CARTON (62756-452-36) > 2.8 mL in 1 CARTRIDGE
Marketing Start Date2020-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62756-452-37 [62756045237]

BYNFEZIA Pen INJECTION
Marketing CategoryNDA
Application NumberNDA213224
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-29

NDC 62756-452-36 [62756045236]

BYNFEZIA Pen INJECTION
Marketing CategoryNDA
Application NumberNDA213224
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-29

Drug Details

Active Ingredients

IngredientStrength
OCTREOTIDE ACETATE2.5 mg/mL

OpenFDA Data

SPL SET ID:20ed4e79-ad4c-426f-859d-83790c00439b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2360543
  • 2360548

    • Pharmacological Class

    • Somatostatin Analog [EPC]
    • Somatostatin Receptor Agonists [MoA]

    NDC Crossover Matching brand name "BYNFEZIA Pen" or generic name "Octreotide Acetate"

    NDCBrand NameGeneric Name
    62756-452BYNFEZIA PenBYNFEZIA Pen
    0641-6174Octreotide AcetateOctreotide Acetate
    0641-6175Octreotide AcetateOctreotide Acetate
    0078-0180Sandostatinoctreotide acetate
    0078-0181Sandostatinoctreotide acetate
    0078-0182Sandostatinoctreotide acetate
    0078-0183Sandostatinoctreotide acetate
    0078-0184Sandostatinoctreotide acetate
    0078-0647Sandostatin LAR Depotoctreotide acetate
    0078-0648Sandostatin LAR Depotoctreotide acetate
    0078-0811Sandostatin LAR Depotoctreotide acetate
    0078-0818Sandostatin LAR Depotoctreotide acetate
    0078-0825Sandostatin LAR Depotoctreotide acetate

    Trademark Results [BYNFEZIA Pen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BYNFEZIA PEN
    BYNFEZIA PEN
    88785164 not registered Live/Pending
    Sun Pharmaceutical Industries Limited
    2020-02-04
    BYNFEZIA PEN
    BYNFEZIA PEN
    88620347 not registered Live/Pending
    Sun Pharmaceutical Industries Limited
    2019-09-17
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