Prescription drug · BLA
Orencia (Abatacept) NDC 0003-2814
Abatacept 50 mg/.4mL · Injection, Solution · Subcutaneous · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-2814-11 | 0000328141100003281411 | 4 SYRINGE, GLASS in 1 CARTON (0003-2814-11) / .4 mL in 1 SYRINGE, GLASSMarketed from Mar 30, 2017 |
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)
- Orencia
- Generic name (nonproprietary)
- abatacept
- Active ingredients
- Abatacept — 50 mg/.4mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125118
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cytokine Activity (Physiologic effect)Recombinant Fusion Proteins (Chemical structure)
- Identifiers
- Product ID 0003-2814_962695b7-21f5-44bb-80e0-cb3b48c80be6SPL ID 962695b7-21f5-44bb-80e0-cb3b48c80be6SPL set ID 0836c6ac-ee37-5640-2fed-a3185a0b16ebRxCUI 616015, 616018, 1145929, 1145932, 1799228, 1799230, 1925254, 1925255, 1925256, 1925257UNII 7D0YB67S97
- Pharmacologic class
- Selective T Cell Costimulation Modulator
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.
- NDC on a medical claim
N400003281411followed by a unit qualifier and the quantityPackage 00003-2814-11. 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 .
Indications (excerpt from the label)
ORENCIA is a selective T cell costimulation modulator indicated for: • the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1) • the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2) • the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3) • the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelat…
Excerpt only. Read the full label for complete information.
About NDC 0003-2814
- What is NDC 0003-2814?
- 0003-2814 is the product NDC for Orencia (abatacept), Abatacept 50 mg/.4mL injection, 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?
- Orencia (Abatacept).
- What is the active ingredient?
- Abatacept.
- 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 Orencia?
- 3 other product NDCs are listed under this name. See all Orencia NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Orencia products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Orenciaabatacept | Abatacept 125 mg/mL | Injection, SolutionSubcutaneous | E.R. Squibb & Sons, L.L.C. | 0003-2188 | 00003-2188-1100003-2188-5100003-2188-90+1 more |
| Orenciaabatacept | Abatacept 87.5 mg/.7mL | Injection, SolutionSubcutaneous | E.R. Squibb & Sons, L.L.C. | 0003-2818 | 00003-2818-11 |
| Orenciaabatacept | Abatacept 250 mg/15mL | Injection, Powder, Lyophilized, For solutionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-2187 | 00003-2187-13 |
Other NDCs under BLA 125118
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Orenciaabatacept | Abatacept 250 mg/15mL | Injection, Powder, Lyophilized, For solutionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-2187 |
| Orenciaabatacept | Abatacept 125 mg/mL | Injection, SolutionSubcutaneous | E.R. Squibb & Sons, L.L.C. | 0003-2188 |
| Orenciaabatacept | Abatacept 87.5 mg/.7mL | Injection, SolutionSubcutaneous | E.R. Squibb & Sons, L.L.C. | 0003-2818 |