What is NDC 0006-5331?

0006-5331 is the product NDC for Welireg (belzutifan), Belzutifan 40 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Welireg?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Welireg NDC 0006-5331 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0006-5331Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00006-5331Add 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
0006-5331-01	0000653310100006533101	90 TABLET, FILM COATED in 1 BOTTLE (0006-5331-01)Marketed from Aug 13, 2021
0006-5331-58	0000653315800006533158	1 BOTTLE in 1 CARTON (0006-5331-58) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Jun 21, 2023 · Sample package
0006-5331-59	0000653315900006533159	1 BOTTLE in 1 CARTON (0006-5331-59) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Jun 21, 2023 · Sample package

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Welireg
Generic name (nonproprietary): belzutifan
Active ingredients: Belzutifan — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Merck Sharp & Dohme LLCNDC labeler code 0006
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215383
Marketing start: Aug 13, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A4 Inducers (Mechanism)Hypoxia-inducible Factor 2 alpha Inhibitors (Mechanism)
Identifiers: Product ID 0006-5331_13120513-3854-4bc3-a648-7ecd807841c2SPL ID 13120513-3854-4bc3-a648-7ecd807841c2
Pharmacologic class: Hypoxia-inducible Factor Inhibitor

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400006533101 followed by a unit qualifier and the quantity

Package 00006-5331-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0006-5331

What is NDC 0006-5331?: 0006-5331 is the product NDC for Welireg (belzutifan), Belzutifan 40 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Welireg (Belzutifan).
What is the active ingredient?: Belzutifan.
Who is the labeler?: Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Welireg?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Welireg (Belzutifan) NDC 0006-5331