erythromycin ethylsuccinate

Generic: erythromycin ethylsuccinate

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erythromycin ethylsuccinate
Generic Name erythromycin ethylsuccinate
Labeler cadila pharmaceuticals limited
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

erythromycin ethylsuccinate 400 mg/5mL

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-103
Product ID 71209-103_f9139eef-80df-428d-a326-a70cc827f9c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216212
Listing Expiration 2026-12-31
Marketing Start 2022-11-21

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 71209103
Hyphenated Format 71209-103

Supplemental Identifiers

RxCUI
686400 686418
UPC
0371209103213
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 ANDA216212 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (71209-103-21)
source: ndc

Packages (1)

71209-103-21 100 mL in 1 BOTTLE (71209-103-21)

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": "f9139eef-80df-428d-a326-a70cc827f9c9", "openfda": {"upc": ["0371209103213"], "unii": ["1014KSJ86F"], "rxcui": ["686400", "686418"], "spl_set_id": ["db70798e-5e07-41d6-afe9-82c272bc5cc0"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (71209-103-21)", "package_ndc": "71209-103-21", "marketing_start_date": "20221121"}], "brand_name": "Erythromycin ethylsuccinate", "product_id": "71209-103_f9139eef-80df-428d-a326-a70cc827f9c9", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "71209-103", "generic_name": "Erythromycin ethylsuccinate", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erythromycin ethylsuccinate", "active_ingredients": [{"name": "ERYTHROMYCIN ETHYLSUCCINATE", "strength": "400 mg/5mL"}], "application_number": "ANDA216212", "marketing_category": "ANDA", "marketing_start_date": "20221121", "listing_expiration_date": "20261231"}