Inflectra (infliximab-dyyb) NDC 0069-0809

NDC codes

FDA NDC Directory

Product NDC (as listed)0069-0809Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00069-0809Add 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
0069-0809-01	00069080901	1 VIAL, SINGLE-USE in 1 CARTON (0069-0809-01) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Nov 21, 2016

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): Inflectra
Generic name (nonproprietary): infliximab-dyyb
Active ingredients: Infliximab — 100 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125544
Marketing start: Nov 21, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
Identifiers: Product ID 0069-0809_248ec8d1-8b3d-480f-8cdc-dbda1f130d17SPL ID 248ec8d1-8b3d-480f-8cdc-dbda1f130d17SPL set ID 37eaca10-d812-48bc-8b8e-b836bfa9968fRxCUI 1790541, 1790546UNII B72HH48FLUUPC 0300690809014
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.

How CPT relates to drug billing

NDC on a medical claim

N400069080901 followed by a unit qualifier and the quantity

Package 00069-0809-01. 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 Jul 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INFLECTRA is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease ( 1.1 ): • 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. • reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. Pediatric Crohn's Disease ( 1.2 ): • 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 th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)