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DOTAREM

NDC 67684-2000 · Guerbet LLC

FDA carries 2 listing records for this NDC; the most recent is shown.

Generic namegadoterate meglumine
Dosage formINJECTION
RouteINTRAVENOUS
Active ingredient(s)GADOTERATE MEGLUMINE
Strength376.9 mg/mL
Pharmacologic classGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
Marketing categoryNDA

Packages

67684-2000-0 — 10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL

67684-2000-1 — 10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL

67684-2000-2 — 10 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL

67684-2000-3 — 10 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIAL

67684-2000-4 — 6 VIAL in 1 PACKAGE (67684-2000-4) / 100 mL in 1 VIAL

Billed under HCPCS

A9575 — Injection, gadoterate meglumine, 0.1 ml Medicare Part B payment limit (ASP + 6%): $0.09

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0407-2943 — gadoterate meglumine, 65219-080 — gadoterate meglumine, 65219-082 — gadoterate meglumine, 65219-084 — gadoterate meglumine, 65219-086 — gadoterate meglumine, 65219-088 — gadoterate meglumine, 67684-2001 — gadoterate meglumine, 67684-3001 — gadoterate meglumine, 70436-123 — gadoterate meglumine

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels