What is NDC 42337-005?

42337-005 is the product NDC for gadobutrol, Gadobutrol 604.72 mg/mL injection, listed with the FDA by Viwit Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

Viwit Pharmaceutical Co., Ltd., NDC labeler code 42337. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for gadobutrol?

16 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

gadobutrol NDC 42337-005 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42337-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42337-0005Add 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 NDC	11-digit (billing)	Package	Copy
42337-005-02	42337000502	10 VIAL, SINGLE-DOSE in 1 CARTON (42337-005-02) / 7.5 mL in 1 VIAL, SINGLE-DOSE (42337-005-01)Marketed from Jun 11, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): gadobutrol
Generic name (nonproprietary): gadobutrol
Active ingredients: Gadobutrol — 604.72 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Viwit Pharmaceutical Co., Ltd.NDC labeler code 42337
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219287
Marketing start: Jun 11, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Magnetic Resonance Contrast Activity (Mechanism)
Identifiers: Product ID 42337-005_57452c1c-7ad5-1e99-e063-6394a90aa2c3SPL ID 57452c1c-7ad5-1e99-e063-6394a90aa2c3SPL set ID 18c67a70-0c1f-46d4-a123-66080090b71bUNII 1BJ477IO2LUPC 0342337005014, 0342337007018, 0342337006011, 0342337005021, 0342337006028
Pharmacologic class: Gadolinium-based Contrast Agent

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

N442337000502 followed by a unit qualifier and the quantity

Package 42337-0005-02. 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 Jul 23, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Gadobutrol Injection is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) Gadobutrol Inje…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42337-005

What is NDC 42337-005?: 42337-005 is the product NDC for gadobutrol, Gadobutrol 604.72 mg/mL injection, listed with the FDA by Viwit Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: gadobutrol.
What is the active ingredient?: Gadobutrol.
Who is the labeler?: Viwit Pharmaceutical Co., Ltd., NDC labeler code 42337. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for gadobutrol?: 16 other product NDCs are listed under this name. See all gadobutrol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other gadobutrol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-2064	70710-2064-06
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-2066	70710-2066-06
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-2065	70710-2065-06
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Viwit Pharmaceutical Co., Ltd.	42337-006	42337-0006-02
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Viwit Pharmaceutical Co., Ltd.	42337-007	42337-0007-02
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-213	70436-0213-82
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-216	70436-0216-51
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-217	70436-0217-80
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-216	70436-0216-81
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-217	70436-0217-50

All 17 gadobutrol NDCs

Other NDCs under ANDA 219287

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

FDA NDC Directory listings under ANDA 219287
Product	Strength	Form · route	Labeler	Product NDC
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-2066
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-2064
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-2065
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Viwit Pharmaceutical Co., Ltd.	42337-006
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Viwit Pharmaceutical Co., Ltd.	42337-007