NDC 62559-630

Erythromycin Ethylsuccinate

Erythromycin Ethylsuccinate

Erythromycin Ethylsuccinate is a Oral Granule, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Ani Pharmaceuticals, Inc.. The primary component is Erythromycin Ethylsuccinate.

Product ID62559-630_25635db5-a227-445d-850a-a98c5f4772ff
NDC62559-630
Product TypeHuman Prescription Drug
Proprietary NameErythromycin Ethylsuccinate
Generic NameErythromycin Ethylsuccinate
Dosage FormGranule, For Suspension
Route of AdministrationORAL
Marketing Start Date2019-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA062055
Labeler NameANI Pharmaceuticals, Inc.
Substance NameERYTHROMYCIN ETHYLSUCCINATE
Active Ingredient Strength200 mg/5mL
Pharm ClassesDecreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 62559-630-01

100 mL in 1 BOTTLE (62559-630-01)
Marketing Start Date2019-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62559-630-01 [62559063001]

Erythromycin Ethylsuccinate GRANULE, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA062055
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-25

Drug Details

Active Ingredients

IngredientStrength
ERYTHROMYCIN ETHYLSUCCINATE200 mg/5mL

OpenFDA Data

SPL SET ID:3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 686418
  • 686400
  • UPC Code
  • 0362559631013
  • 0362559630016
  • Pharmacological Class

    • Decreased Sebaceous Gland Activity [PE]
    • Macrolide [EPC]
    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]
    • Decreased Sebaceous Gland Activity [PE]
    • Macrolide [EPC]
    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]