vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vancomycin hydrochloride
Generic Name vancomycin hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

vancomycin hydrochloride 1.25 g/25mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-823
Product ID 67457-823_a0a9dc82-4ffe-4798-8ec4-f4021bf6fc9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209481
Listing Expiration 2026-12-31
Marketing Start 2018-08-31

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457823
Hyphenated Format 67457-823

Supplemental Identifiers

RxCUI
1807518 2049888 2049890 2049891
UPC
0367457822990
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 NDA209481 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.25 g/25mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-823-99) / 25 mL in 1 VIAL, SINGLE-DOSE (67457-823-12)
source: ndc

Packages (1)

67457-823-99 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-823-99) / 25 mL in 1 VIAL, SINGLE-DOSE (67457-823-12)

Ingredients (1)

vancomycin hydrochloride (1.25 g/25mL)

Linked Drug Pages (1)

Vancomycin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a0a9dc82-4ffe-4798-8ec4-f4021bf6fc9f", "openfda": {"upc": ["0367457822990"], "unii": ["71WO621TJD"], "rxcui": ["1807518", "2049888", "2049890", "2049891"], "spl_set_id": ["caf22ccb-df75-45ea-a1d0-ccb2d37272fb"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (67457-823-99)  / 25 mL in 1 VIAL, SINGLE-DOSE (67457-823-12)", "package_ndc": "67457-823-99", "marketing_start_date": "20180831"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "67457-823_a0a9dc82-4ffe-4798-8ec4-f4021bf6fc9f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "67457-823", "generic_name": "Vancomycin Hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "1.25 g/25mL"}], "application_number": "NDA209481", "marketing_category": "NDA", "marketing_start_date": "20180831", "listing_expiration_date": "20261231"}