erythromycin

Generic: erythromycin

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

Drug Facts

Product Profile

Brand Name erythromycin
Generic Name erythromycin
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

erythromycin 500 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-243
Product ID 75834-243_e40dea9d-181d-4775-8912-ac1fc0d84b23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213628
Listing Expiration 2026-12-31
Marketing Start 2021-07-15

Pharmacologic Class

Established (EPC)
macrolide [epc] macrolide antimicrobial [epc]
Chemical Structure
macrolides [cs]
Physiologic Effect
decreased sebaceous gland activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834243
Hyphenated Format 75834-243

Supplemental Identifiers

RxCUI
197650 598006
UPC
0375834242019 0375834243016 0375834242309 0375834243306
UNII
63937KV33D
NUI
N0000009982 N0000175877 N0000175935 M0028311

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 (source: ndc)
Generic Name erythromycin (source: ndc)
Application Number ANDA213628 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (75834-243-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (75834-243-30)
source: ndc

Packages (2)

75834-243-01 100 TABLET, FILM COATED in 1 BOTTLE (75834-243-01) 75834-243-30 30 TABLET, FILM COATED in 1 BOTTLE (75834-243-30)

Ingredients (1)

erythromycin (500 mg/1)

Linked Drug Pages (1)

ERYTHROMYCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e40dea9d-181d-4775-8912-ac1fc0d84b23", "openfda": {"nui": ["N0000009982", "N0000175877", "N0000175935", "M0028311"], "upc": ["0375834242019", "0375834243016", "0375834242309", "0375834243306"], "unii": ["63937KV33D"], "rxcui": ["197650", "598006"], "spl_set_id": ["aa61cb37-5fc5-4225-b894-1d660386777f"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_pe": ["Decreased Sebaceous Gland Activity [PE]"], "pharm_class_epc": ["Macrolide [EPC]", "Macrolide Antimicrobial [EPC]"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (75834-243-01)", "package_ndc": "75834-243-01", "marketing_start_date": "20210715"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (75834-243-30)", "package_ndc": "75834-243-30", "marketing_start_date": "20210715"}], "brand_name": "ERYTHROMYCIN", "product_id": "75834-243_e40dea9d-181d-4775-8912-ac1fc0d84b23", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "75834-243", "generic_name": "ERYTHROMYCIN", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERYTHROMYCIN", "active_ingredients": [{"name": "ERYTHROMYCIN", "strength": "500 mg/1"}], "application_number": "ANDA213628", "marketing_category": "ANDA", "marketing_start_date": "20210715", "listing_expiration_date": "20261231"}