vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vancomycin hydrochloride
Generic Name vancomycin hydrochloride
Labeler ani pharmaceuticals, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vancomycin hydrochloride 250 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-830
Product ID 62559-830_c02af1aa-0e2c-4174-9349-8838710838ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA061667
Listing Expiration 2027-12-31
Marketing Start 2019-09-09

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559830
Hyphenated Format 62559-830

Supplemental Identifiers

RxCUI
2000134
UPC
0362559830805
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 ANDA061667 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 300 mL in 1 BOTTLE, PLASTIC (62559-830-03)
  • 150 mL in 1 BOTTLE, PLASTIC (62559-830-55)
  • 80 mL in 1 BOTTLE, PLASTIC (62559-830-80)
source: ndc

Packages (3)

62559-830-03 300 mL in 1 BOTTLE, PLASTIC (62559-830-03) 62559-830-55 150 mL in 1 BOTTLE, PLASTIC (62559-830-55) 62559-830-80 80 mL in 1 BOTTLE, PLASTIC (62559-830-80)

Ingredients (1)

vancomycin hydrochloride (250 mg/5mL)

Linked Drug Pages (1)

Vancomycin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c02af1aa-0e2c-4174-9349-8838710838ee", "openfda": {"upc": ["0362559830805"], "unii": ["71WO621TJD"], "rxcui": ["2000134"], "spl_set_id": ["27d06545-1af0-4dcd-926d-58d4a9492ec3"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 mL in 1 BOTTLE, PLASTIC (62559-830-03)", "package_ndc": "62559-830-03", "marketing_start_date": "20190909"}, {"sample": false, "description": "150 mL in 1 BOTTLE, PLASTIC (62559-830-55)", "package_ndc": "62559-830-55", "marketing_start_date": "20190909"}, {"sample": false, "description": "80 mL in 1 BOTTLE, PLASTIC (62559-830-80)", "package_ndc": "62559-830-80", "marketing_start_date": "20190909"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "62559-830_c02af1aa-0e2c-4174-9349-8838710838ee", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "62559-830", "generic_name": "Vancomycin Hydrochloride", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "250 mg/5mL"}], "application_number": "ANDA061667", "marketing_category": "ANDA", "marketing_start_date": "20190909", "listing_expiration_date": "20271231"}