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Gadobutrol

NDC 65219-281, Gadobutrol, injection, from Fresenius Kabi USA, LLC.

Product NDC
65219-281
Status
Listed
Labeler
Fresenius Kabi USA, LLC
Dosage form
INJECTION
Route
INTRAVENOUS
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA215061
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/65219-281 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • GADOBUTROL604.72 mg/mL

Pharmacologic classes

Gadolinium-based Contrast Agent [EPC]; Magnetic Resonance Contrast Activity [MoA]

Package NDCNDC-11Package
65219-281-02652190281025 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00)
65219-281-07652190281072 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)
65219-281-10652190281102 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)
65219-281-15652190281152 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)

Linked data

RxNorm, label and prices

RxNorm concepts

RxNorm links no concept to this product's packages.

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/007696d0-4b62-4937-9640-4ad619504df4

  • Medicare Part B payment limits (ASP)

    GET /v1/drugs/asp?ndc=65219-281

Use it

Look up 65219-281 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/65219-281 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 65219-281. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.
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Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.