firvanq

Generic: vancomycin hydrochloride

Labeler: azurity pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name firvanq
Generic Name vancomycin hydrochloride
Labeler azurity pharmaceuticals, inc
Dosage Form KIT
Manufacturer
Azurity Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 65628-205
Product ID 65628-205_4606f496-387d-f0e0-e063-6294a90ad37a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208910
Listing Expiration 2026-12-31
Marketing Start 2018-01-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65628205
Hyphenated Format 65628-205

Supplemental Identifiers

RxCUI
2000127 2000133 2000134 2000136

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 firvanq (source: ndc)
Generic Name vancomycin hydrochloride (source: ndc)
Application Number NDA208910 (source: ndc)

Resolved Composition

Strengths
  • 3.75 g
  • 7.5 g
  • 15.0 g
  • 147 ml
  • 295 ml
  • 145 ml
  • 289 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (65628-205-10) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE
source: ndc

Packages (1)

65628-205-10 1 KIT in 1 CARTON (65628-205-10) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

FIRVANQ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "4606f496-387d-f0e0-e063-6294a90ad37a", "openfda": {"rxcui": ["2000127", "2000133", "2000134", "2000136"], "spl_set_id": ["5aca5508-b577-446c-9980-ab4c7582b4b9"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (65628-205-10)  *  7.5 g in 1 BOTTLE *  295 mL in 1 BOTTLE", "package_ndc": "65628-205-10", "marketing_start_date": "20180126"}], "brand_name": "FIRVANQ", "product_id": "65628-205_4606f496-387d-f0e0-e063-6294a90ad37a", "dosage_form": "KIT", "product_ndc": "65628-205", "generic_name": "vancomycin hydrochloride", "labeler_name": "Azurity Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FIRVANQ", "application_number": "NDA208910", "marketing_category": "NDA", "marketing_start_date": "20180126", "listing_expiration_date": "20261231"}