erythromycin

Generic: erythromycin

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erythromycin
Generic Name erythromycin
Labeler padagis israel pharmaceuticals ltd
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

erythromycin 20 mg/mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-038
Product ID 45802-038_81c83ddb-5432-484c-8a60-e51677a62c6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA063038
Listing Expiration 2026-12-31
Marketing Start 2011-12-19

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 45802038
Hyphenated Format 45802-038

Supplemental Identifiers

RxCUI
318202
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 ANDA063038 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45802-038-46) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

45802-038-46 1 BOTTLE in 1 CARTON (45802-038-46) / 60 mL in 1 BOTTLE

Ingredients (1)

erythromycin (20 mg/mL)

Linked Drug Pages (1)

erythromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "81c83ddb-5432-484c-8a60-e51677a62c6b", "openfda": {"nui": ["N0000009982", "N0000175877", "N0000175935", "M0028311"], "unii": ["63937KV33D"], "rxcui": ["318202"], "spl_set_id": ["40edf1bd-42bb-4662-aff6-01fcc133c05d"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_pe": ["Decreased Sebaceous Gland Activity [PE]"], "pharm_class_epc": ["Macrolide [EPC]", "Macrolide Antimicrobial [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-038-46)  / 60 mL in 1 BOTTLE", "package_ndc": "45802-038-46", "marketing_start_date": "20111219"}], "brand_name": "erythromycin", "product_id": "45802-038_81c83ddb-5432-484c-8a60-e51677a62c6b", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "45802-038", "generic_name": "erythromycin", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "erythromycin", "active_ingredients": [{"name": "ERYTHROMYCIN", "strength": "20 mg/mL"}], "application_number": "ANDA063038", "marketing_category": "ANDA", "marketing_start_date": "20111219", "listing_expiration_date": "20261231"}