Prescription drug · BLA

Hulio (adalimumab-fkjp) NDC 83257-016

Kit · Biocon Biologics Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)83257-016Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83257-0016Add 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 NDC11-digit (billing)PackageCopy
83257-016-42832570016422 TRAY in 1 KIT (83257-016-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKETMarketed from Dec 30, 2023

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)
Hulio
Generic name (nonproprietary)
adalimumab-fkjp
Dosage form
Kit
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761154
Marketing start
Marketing end
Identifiers
Product ID 83257-016_e4767905-1306-0022-2a53-8c5d4b218e2fSPL ID e4767905-1306-0022-2a53-8c5d4b218e2fSPL set ID 661ad70b-c313-2899-8a7e-7a67bd897ca9RxCUI 797544, 2640404, 2640410, 2640412, 2640415, 2640417, 2640418

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.

NDC on a medical claim

N483257001642 followed by a unit qualifier and the quantity

Package 83257-0016-42. 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)

HULIO is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. J uvenile Idiopathic Arthritis (JIA) ( 1.2 ) : reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA) ( 1.3 ) : reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. A nkylosing Spondylitis (AS) ( 1.4 ): reducing signs and …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761154

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761154
ProductStrengthForm · routeLabelerProduct NDC
Adalimumabadalimumab-fkjp—KitBiocon Biologics Inc83257-020
Hulioadalimumab-fkjp—KitBiocon Biologics Inc83257-019
Adalimumabadalimumab-fkjp—KitBiocon Biologics Inc83257-021
Adalimumabadalimumab-fkjp—KitBiocon Biologics Inc83257-022

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Hulio (adalimumab-fkjp) NDC 83257-016 | Med-Code