erythromycin ethylsuccinate

Generic: erythromycin ethylsuccinate

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erythromycin ethylsuccinate
Generic Name erythromycin ethylsuccinate
Labeler ani pharmaceuticals, inc.
Dosage Form GRANULE, FOR SUSPENSION
Routes
ORAL
Active Ingredients

erythromycin ethylsuccinate 400 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-631
Product ID 62559-631_9bae85e8-ec96-4424-a640-27860f8f319e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062055
Listing Expiration 2026-12-31
Marketing Start 2019-03-25

Pharmacologic Class

Classes
decreased sebaceous gland activity [pe] macrolide antimicrobial [epc] macrolide [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559631
Hyphenated Format 62559-631

Supplemental Identifiers

RxCUI
686400 686418
UPC
0362559631013 0362559630016
UNII
1014KSJ86F

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name erythromycin ethylsuccinate (source: ndc)
Generic Name erythromycin ethylsuccinate (source: ndc)
Application Number ANDA062055 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (62559-631-01)
source: ndc

Packages (1)

62559-631-01 100 mL in 1 BOTTLE (62559-631-01)

Ingredients (1)

erythromycin ethylsuccinate (400 mg/5mL)

Linked Drug Pages (1)

Erythromycin Ethylsuccinate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9bae85e8-ec96-4424-a640-27860f8f319e", "openfda": {"upc": ["0362559631013", "0362559630016"], "unii": ["1014KSJ86F"], "rxcui": ["686400", "686418"], "spl_set_id": ["3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (62559-631-01)", "package_ndc": "62559-631-01", "marketing_start_date": "20190325"}], "brand_name": "Erythromycin Ethylsuccinate", "product_id": "62559-631_9bae85e8-ec96-4424-a640-27860f8f319e", "dosage_form": "GRANULE, FOR SUSPENSION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "62559-631", "generic_name": "Erythromycin Ethylsuccinate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erythromycin Ethylsuccinate", "active_ingredients": [{"name": "ERYTHROMYCIN ETHYLSUCCINATE", "strength": "400 mg/5mL"}], "application_number": "ANDA062055", "marketing_category": "ANDA", "marketing_start_date": "20190325", "listing_expiration_date": "20261231"}