What is NDC 0003-0371?

0003-0371 is the product NDC for Nulojix (belatacept), Belatacept 250 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 1 package NDC, shown above in 10- and 11-digit form.

E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nulojix?

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.

Nulojix NDC 0003-0371 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0003-0371Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00003-0371Add 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
0003-0371-13	0000303711300003037113	1 VIAL, SINGLE-USE in 1 CARTON (0003-0371-13) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USEMarketed from Jun 15, 2011

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): Nulojix
Generic name (nonproprietary): belatacept
Active ingredients: Belatacept — 250 mg/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125288
Marketing start: Jun 15, 2011
Listing expires: Dec 31, 2027
Other FDA classes: CD80-directed Antibody Interactions (Mechanism)CD86-directed Antibody Interactions (Mechanism)T Lymphocyte Costimulation Activity Blockade (Physiologic effect)
Identifiers: Product ID 0003-0371_9057087d-7e59-4e5a-8e4a-96a532efb0abSPL ID 9057087d-7e59-4e5a-8e4a-96a532efb0abSPL set ID c16ac648-d5d2-9f7d-8637-e2328572754eRxCUI 1112976, 1112980UNII E3B2GI648A
Pharmacologic class: Selective T Cell Costimulation Blocker

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

N400003037113 followed by a unit qualifier and the quantity

Package 00003-0371-13. 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 28, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

• NULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. (1.1) • Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. (1.1) Limitations of Use : • Use only in patients who are EBV seropositive. (1.2 , 4 , 5.1) • Use has not been established for the prophylaxis of organ rejection in transplanted organs other than the kidney. (1.2 , 5.6) 1.1 Adult Kidney Transplant Recipients NULOJIX ® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. NULOJIX is to be used in combination with basiliximab induction, mycopheno…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0003-0371

What is NDC 0003-0371?: 0003-0371 is the product NDC for Nulojix (belatacept), Belatacept 250 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nulojix (Belatacept).
What is the active ingredient?: Belatacept.
Who is the labeler?: E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nulojix?: 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.

Nulojix (Belatacept) NDC 0003-0371