erythromycin ethylsuccinate

Generic: erythromycin ethylsuccinate

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

Drug Facts

Product Profile

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

erythromycin ethylsuccinate 200 mg/5mL

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-295
Product ID 75834-295_7f06e8f4-15fb-4e18-b57e-457e7e20d331
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216212
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

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 75834295
Hyphenated Format 75834-295

Supplemental Identifiers

RxCUI
686400 686418
UPC
0375834295015 0375834294018
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
  • 200 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (75834-295-01)
source: ndc

Packages (1)

75834-295-01 100 mL in 1 BOTTLE (75834-295-01)

Ingredients (1)

erythromycin ethylsuccinate (200 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": "7f06e8f4-15fb-4e18-b57e-457e7e20d331", "openfda": {"upc": ["0375834295015", "0375834294018"], "unii": ["1014KSJ86F"], "rxcui": ["686400", "686418"], "spl_set_id": ["46f74c4f-10fc-44cf-aec4-d113f49149bc"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (75834-295-01)", "package_ndc": "75834-295-01", "marketing_start_date": "20230201"}], "brand_name": "Erythromycin Ethylsuccinate", "product_id": "75834-295_7f06e8f4-15fb-4e18-b57e-457e7e20d331", "dosage_form": "SUSPENSION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "75834-295", "generic_name": "Erythromycin Ethylsuccinate", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erythromycin Ethylsuccinate", "active_ingredients": [{"name": "ERYTHROMYCIN ETHYLSUCCINATE", "strength": "200 mg/5mL"}], "application_number": "ANDA216212", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}