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 hydrochloride 500 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9356
Product ID 0143-9356_431d7445-e798-40a7-a8aa-6a8b1ac5813f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203300
Listing Expiration 2026-12-31
Marketing Start 2020-08-11

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439356
Hyphenated Format 0143-9356

Supplemental Identifiers

RxCUI
1807513 1807516
UNII
71WO621TJD

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 ANDA203300 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0143-9356-25) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9356-01)
source: ndc

Packages (1)

0143-9356-25 25 VIAL in 1 CARTON (0143-9356-25) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9356-01)

Ingredients (1)

vancomycin hydrochloride (500 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": "431d7445-e798-40a7-a8aa-6a8b1ac5813f", "openfda": {"unii": ["71WO621TJD"], "rxcui": ["1807513", "1807516"], "spl_set_id": ["2f5d3131-8ddc-43a5-91f7-947c531796e7"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0143-9356-25)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9356-01)", "package_ndc": "0143-9356-25", "marketing_start_date": "20200811"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "0143-9356_431d7445-e798-40a7-a8aa-6a8b1ac5813f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "0143-9356", "generic_name": "Vancomycin Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA203300", "marketing_category": "ANDA", "marketing_start_date": "20200811", "listing_expiration_date": "20261231"}