xacduro

Generic: sulbactam and durlobactam

Labeler: la jolla pharmaceutical company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xacduro
Generic Name sulbactam and durlobactam
Labeler la jolla pharmaceutical company
Dosage Form KIT
Manufacturer
La Jolla Pharmaceutical Company

Identifiers & Regulatory

Product NDC 68547-111
Product ID 68547-111_2606ce2c-ad3a-4c58-be0d-9a696d366d64
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216974
Listing Expiration 2026-12-31
Marketing Start 2023-06-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68547111
Hyphenated Format 68547-111

Supplemental Identifiers

RxCUI
2665012 2665017

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 xacduro (source: ndc)
Generic Name sulbactam and durlobactam (source: ndc)
Application Number NDA216974 (source: ndc)

Resolved Composition

Strengths
  • 1 g
  • 0.5 g
source: label
Packaging
  • 1 KIT in 1 CARTON (68547-111-10) * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30)
source: ndc

Packages (1)

68547-111-10 1 KIT in 1 CARTON (68547-111-10) * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Xacduro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "2606ce2c-ad3a-4c58-be0d-9a696d366d64", "openfda": {"rxcui": ["2665012", "2665017"], "spl_set_id": ["c0167aec-a89d-4e96-afe5-2ccf3e89fe72"], "manufacturer_name": ["La Jolla Pharmaceutical Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (68547-111-10)  *  5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20)  *  2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30)", "package_ndc": "68547-111-10", "marketing_start_date": "20230606"}], "brand_name": "Xacduro", "product_id": "68547-111_2606ce2c-ad3a-4c58-be0d-9a696d366d64", "dosage_form": "KIT", "product_ndc": "68547-111", "generic_name": "sulbactam and durlobactam", "labeler_name": "La Jolla Pharmaceutical Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xacduro", "application_number": "NDA216974", "marketing_category": "NDA", "marketing_start_date": "20230606", "listing_expiration_date": "20261231"}