vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vancomycin hydrochloride
Generic Name vancomycin hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

vancomycin 750 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9355
Product ID 0143-9355_e298d434-6e7e-4a46-9744-a098386a89d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206616
Listing Expiration 2026-12-31
Marketing Start 2018-10-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439355
Hyphenated Format 0143-9355

Supplemental Identifiers

RxCUI
1807518
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 hydrochloride (source: ndc)
Generic Name vancomycin hydrochloride (source: ndc)
Application Number ANDA206616 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9355-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9355-01)
source: ndc

Packages (1)

0143-9355-10 10 VIAL in 1 CARTON (0143-9355-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9355-01)

Ingredients (1)

vancomycin (750 mg/1)

Linked Drug Pages (1)

Vancomycin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e298d434-6e7e-4a46-9744-a098386a89d6", "openfda": {"nui": ["N0000175491", "M0009481"], "unii": ["6Q205EH1VU"], "rxcui": ["1807518"], "spl_set_id": ["86950e7c-0114-47e9-8891-e09e595c48c3"], "pharm_class_cs": ["Glycopeptides [CS]"], "pharm_class_epc": ["Glycopeptide Antibacterial [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9355-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9355-01)", "package_ndc": "0143-9355-10", "marketing_start_date": "20181003"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "0143-9355_e298d434-6e7e-4a46-9744-a098386a89d6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "0143-9355", "generic_name": "Vancomycin Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN", "strength": "750 mg/1"}], "application_number": "ANDA206616", "marketing_category": "ANDA", "marketing_start_date": "20181003", "listing_expiration_date": "20261231"}