vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

vancomycin hydrochloride 125 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-390
Product ID 62559-390_cf20df7a-8689-49f9-a77b-a0a832fea8fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050606
Listing Expiration 2027-12-31
Marketing Start 2015-10-26

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559390
Hyphenated Format 62559-390

Supplemental Identifiers

RxCUI
313570 313571
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 NDA050606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (62559-390-20) / 10 CAPSULE in 1 BLISTER PACK
  • 50 CAPSULE in 1 BOTTLE (62559-390-50)
source: ndc

Packages (2)

62559-390-20 2 BLISTER PACK in 1 CARTON (62559-390-20) / 10 CAPSULE in 1 BLISTER PACK 62559-390-50 50 CAPSULE in 1 BOTTLE (62559-390-50)

Ingredients (1)

vancomycin hydrochloride (125 mg/1)

Linked Drug Pages (1)

vancomycin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cf20df7a-8689-49f9-a77b-a0a832fea8fa", "openfda": {"unii": ["71WO621TJD"], "rxcui": ["313570", "313571"], "spl_set_id": ["3707ad2e-5c82-4111-a370-e518e5e7e4c5"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (62559-390-20)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "62559-390-20", "marketing_start_date": "20151026"}, {"sample": false, "description": "50 CAPSULE in 1 BOTTLE (62559-390-50)", "package_ndc": "62559-390-50", "marketing_start_date": "20161220"}], "brand_name": "vancomycin hydrochloride", "product_id": "62559-390_cf20df7a-8689-49f9-a77b-a0a832fea8fa", "dosage_form": "CAPSULE", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "62559-390", "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": "125 mg/1"}], "application_number": "NDA050606", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20151026", "listing_expiration_date": "20271231"}