vibativ

Generic: telavancin hydrochloride

Labeler: cumberland pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vibativ
Generic Name telavancin hydrochloride
Labeler cumberland pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

telavancin hydrochloride 15 mg/mL

Manufacturer
Cumberland Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 66220-315
Product ID 66220-315_7664f8a4-33c4-4f30-998e-86333640c44d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022110
Listing Expiration 2026-12-31
Marketing Start 2021-01-01

Pharmacologic Class

Classes
lipoglycopeptide antibacterial [epc] lipoglycopeptides [ext]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66220315
Hyphenated Format 66220-315

Supplemental Identifiers

RxCUI
1728082 1728085
UNII
0701472ZG0

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 vibativ (source: ndc)
Generic Name telavancin hydrochloride (source: ndc)
Application Number NDA022110 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-11) / 50 mL in 1 VIAL, SINGLE-DOSE
  • 12 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-22) / 50 mL in 1 VIAL, SINGLE-DOSE
  • 4 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-44) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (3)

66220-315-11 1 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-11) / 50 mL in 1 VIAL, SINGLE-DOSE 66220-315-22 12 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-22) / 50 mL in 1 VIAL, SINGLE-DOSE 66220-315-44 4 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-44) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

telavancin hydrochloride (15 mg/mL)

Linked Drug Pages (1)

VIBATIV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7664f8a4-33c4-4f30-998e-86333640c44d", "openfda": {"unii": ["0701472ZG0"], "rxcui": ["1728082", "1728085"], "spl_set_id": ["5359b759-db7c-4672-9e8a-59c93869bd91"], "manufacturer_name": ["Cumberland Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-11)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "66220-315-11", "marketing_start_date": "20210101"}, {"sample": false, "description": "12 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-22)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "66220-315-22", "marketing_start_date": "20210101"}, {"sample": false, "description": "4 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-44)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "66220-315-44", "marketing_start_date": "20231201"}], "brand_name": "VIBATIV", "product_id": "66220-315_7664f8a4-33c4-4f30-998e-86333640c44d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipoglycopeptide Antibacterial [EPC]", "Lipoglycopeptides [EXT]"], "product_ndc": "66220-315", "generic_name": "telavancin hydrochloride", "labeler_name": "Cumberland Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIBATIV", "active_ingredients": [{"name": "TELAVANCIN HYDROCHLORIDE", "strength": "15 mg/mL"}], "application_number": "NDA022110", "marketing_category": "NDA", "marketing_start_date": "20210101", "listing_expiration_date": "20261231"}