orlynvah

Generic: sulopenem etzadroxil and probenecid

Labeler: iterum therapeutics us limited
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name orlynvah
Generic Name sulopenem etzadroxil and probenecid
Labeler iterum therapeutics us limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

probenecid 500 mg/1, sulopenem etzadroxil 500 mg/1

Manufacturer
ITERUM THERAPEUTICS US LIMITED

Identifiers & Regulatory

Product NDC 81153-100
Product ID 81153-100_abcb22dd-7c10-4459-a98c-d03582b426a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213972
Listing Expiration 2027-12-31
Marketing Start 2025-07-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81153100
Hyphenated Format 81153-100

Supplemental Identifiers

RxCUI
2717843 2717850
UNII
PO572Z7917 492M3I304T

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 orlynvah (source: ndc)
Generic Name sulopenem etzadroxil and probenecid (source: ndc)
Application Number NDA213972 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

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

Ingredients (2)

probenecid (500 mg/1) sulopenem etzadroxil (500 mg/1)

Linked Drug Pages (1)

ORLYNVAH ndc-match (0.9)

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"}