vancomycin

Generic: vancomycin

Labeler: xellia pharmaceuticals usa llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vancomycin
Generic Name vancomycin
Labeler xellia pharmaceuticals usa llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

vancomycin 500 mg/100mL

Manufacturer
Xellia Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 70594-041
Product ID 70594-041_e49b6589-caca-4c8f-8c57-55a1ee7774cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211962
Listing Expiration 2026-12-31
Marketing Start 2019-02-15

Pharmacologic Class

Established (EPC)
glycopeptide antibacterial [epc]
Chemical Structure
glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70594041
Hyphenated Format 70594-041

Supplemental Identifiers

RxCUI
1807508 1807510 1807511 2118448 2118449 2387078 2387079
UNII
6Q205EH1VU
NUI
N0000175491 M0009481

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 vancomycin (source: ndc)
Generic Name vancomycin (source: ndc)
Application Number NDA211962 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 6 BAG in 1 CARTON (70594-041-02) / 100 mL in 1 BAG (70594-041-01)
  • 12 BAG in 1 CARTON (70594-041-03) / 100 mL in 1 BAG (70594-041-01)
source: ndc

Packages (2)

70594-041-02 6 BAG in 1 CARTON (70594-041-02) / 100 mL in 1 BAG (70594-041-01) 70594-041-03 12 BAG in 1 CARTON (70594-041-03) / 100 mL in 1 BAG (70594-041-01)

Ingredients (1)

vancomycin (500 mg/100mL)

Linked Drug Pages (1)

Vancomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e49b6589-caca-4c8f-8c57-55a1ee7774cc", "openfda": {"nui": ["N0000175491", "M0009481"], "unii": ["6Q205EH1VU"], "rxcui": ["1807508", "1807510", "1807511", "2118448", "2118449", "2387078", "2387079"], "spl_set_id": ["60bee69b-be70-412c-9e83-a24a0a8a5e7b"], "pharm_class_cs": ["Glycopeptides [CS]"], "pharm_class_epc": ["Glycopeptide Antibacterial [EPC]"], "manufacturer_name": ["Xellia Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BAG in 1 CARTON (70594-041-02)  / 100 mL in 1 BAG (70594-041-01)", "package_ndc": "70594-041-02", "marketing_start_date": "20190215"}, {"sample": false, "description": "12 BAG in 1 CARTON (70594-041-03)  / 100 mL in 1 BAG (70594-041-01)", "package_ndc": "70594-041-03", "marketing_start_date": "20190215"}], "brand_name": "Vancomycin", "product_id": "70594-041_e49b6589-caca-4c8f-8c57-55a1ee7774cc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "70594-041", "generic_name": "Vancomycin", "labeler_name": "Xellia Pharmaceuticals USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin", "active_ingredients": [{"name": "VANCOMYCIN", "strength": "500 mg/100mL"}], "application_number": "NDA211962", "marketing_category": "NDA", "marketing_start_date": "20190215", "listing_expiration_date": "20261231"}