Prescription drug · BLA
Renflexis (infliximab) NDC 78206-162
Infliximab 100 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-162-01 | 78206016201 | 1 VIAL in 1 CARTON (78206-162-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (78206-162-99)Marketed from Jun 1, 2021 |
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)
- Renflexis
- Generic name (nonproprietary)
- infliximab
- Active ingredients
- Infliximab — 100 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Organon LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761054
- Marketing start
- Listing expires
- Other FDA classes
- Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
- Identifiers
- Product ID 78206-162_20c46bec-ae83-4851-98b7-88222a8ff88aSPL ID 20c46bec-ae83-4851-98b7-88222a8ff88aSPL set ID dbf738c4-3fac-4422-a9d8-51d9c83a8789RxCUI 1927285, 1927290UNII B72HH48FLU
- Pharmacologic class
- Tumor Necrosis Factor 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 codeMed-Code curated
J1745 — Injection, infliximab, excludes biosimilar, 10 mg
Billing unit: 10 mg. Units on the claim = dose given ÷ 10 mg.
Infliximab biosimilars have their own HCPCS codes.
- 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
N478206016201followed by a unit qualifier and the quantityPackage 78206-0162-01. 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)
RENFLEXIS is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. ( 1.1 ) Pediatric Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy.…
Excerpt only. Read the full label for complete information.