Prescription drug · NDA

Elucirem (gadopiclenol) NDC 67684-4231

Gadopiclenol 485.1 mg/mL · Injection · Intravenous · Guerbet LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67684-4231Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67684-4231Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
67684-4231-1676844231011 VIAL in 1 CARTON (67684-4231-1) / 7.5 mL in 1 VIALMarketed from Sep 21, 2022
67684-4231-26768442310210 VIAL in 1 CARTON (67684-4231-2) / 7.5 mL in 1 VIALMarketed from Sep 21, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Elucirem
Generic name (nonproprietary)
gadopiclenol
Active ingredients
Gadopiclenol — 485.1 mg/mL
Dosage form
Injection
Route
Intravenous
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 216986
Marketing start
Listing expires
Identifiers
Product ID 67684-4231_e15d694f-7809-4715-a8c8-a432c05760ccSPL ID e15d694f-7809-4715-a8c8-a432c05760ccSPL set ID ca582f31-1042-487f-82e4-533f1b541902UNII S276568KOYUPC 0367684424028, 0367684423120

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N467684423101 followed by a unit qualifier and the quantity

Package 67684-4231-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). ELUCIREM is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216986

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 216986
ProductStrengthForm · routeLabelerProduct NDC
VuewaygadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousBRACCO DIAGNOSTICS INC0270-7015
EluciremgadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousGuerbet LLC67684-4230
EluciremgadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousGuerbet LLC67684-4233
EluciremgadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousGuerbet LLC67684-4232
EluciremgadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousGuerbet LLC67684-4250
EluciremgadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousGuerbet LLC67684-4240
EluciremgadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousGuerbet LLC67684-4241
EluciremgadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousGuerbet LLC67684-4242
VuewaygadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousBRACCO DIAGNOSTICS INC0270-7020
EluciremgadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousGuerbet LLC67684-4251
VuewaygadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousBRACCO DIAGNOSTICS INC0270-7025
VuewaygadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousBRACCO DIAGNOSTICS INC0270-7030
VuewaygadopiclenolGadopiclenol 485.1 mg/mLInjectionIntravenousBRACCO DIAGNOSTICS INC0270-7035

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Elucirem (gadopiclenol) NDC 67684-4231 | Med-Code