Package 81153-100-01

Brand: orlynvah

Generic: sulopenem etzadroxil and probenecid
NDC Package

Package Facts

Identity

Package NDC 81153-100-01
Digits Only 8115310001
Product NDC 81153-100
Product ID 81153-100_abcb22dd-7c10-4459-a98c-d03582b426a3
Description

1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2025-07-01
Brand orlynvah
Generic sulopenem etzadroxil and probenecid
Sample Package No

Linked Drug Pages (1)

ORLYNVAH ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "abcb22dd-7c10-4459-a98c-d03582b426a3", "openfda": {"unii": ["PO572Z7917", "492M3I304T"], "rxcui": ["2717843", "2717850"], "spl_set_id": ["24c451c0-4cfb-37f3-e063-6394a90a895e"], "manufacturer_name": ["ITERUM THERAPEUTICS US LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (81153-100-01)  / 10 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "81153-100-01", "marketing_start_date": "20250701"}], "brand_name": "ORLYNVAH", "product_id": "81153-100_abcb22dd-7c10-4459-a98c-d03582b426a3", "dosage_form": "TABLET, FILM COATED", "product_ndc": "81153-100", "generic_name": "sulopenem etzadroxil and probenecid", "labeler_name": "ITERUM THERAPEUTICS US LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ORLYNVAH", "active_ingredients": [{"name": "PROBENECID", "strength": "500 mg/1"}, {"name": "SULOPENEM ETZADROXIL", "strength": "500 mg/1"}], "application_number": "NDA213972", "marketing_category": "NDA", "marketing_start_date": "20250701", "listing_expiration_date": "20271231"}