Enbrel (etanercept) NDC 58406-010

NDC codes

FDA NDC Directory

Product NDC (as listed)58406-010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58406-0010Add 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
58406-010-04	58406001004	4 SYRINGE in 1 CARTON (58406-010-04) / .5 mL in 1 SYRINGE (58406-010-01)Marketed from Jun 7, 2019
58406-010-96	58406001096	1 SYRINGE in 1 CARTON (58406-010-96) / .5 mL in 1 SYRINGEMarketed from Jun 7, 2019 · Sample package

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): Enbrel
Generic name (nonproprietary): etanercept
Active ingredients: Etanercept — 25 mg/.5mL
Dosage form: Solution
Route: Subcutaneous
Labeler: Immunex Corporation
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 103795
Marketing start: Jun 7, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
Identifiers: Product ID 58406-010_de3ee3bd-0047-4365-a4c7-5786521a1649SPL ID de3ee3bd-0047-4365-a4c7-5786521a1649SPL set ID a002b40c-097d-47a5-957f-7a7b1807af7fRxCUI 253014, 261105, 727757, 802652, 809158, 809159, 1653223, 1653225, 2182338, 2182340, 2392140, 2392142UNII OP401G7OJCUPC 0358406021045, 0358406055040, 0000000000000, 0358406010049, 0358406044044
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 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

N458406001004 followed by a unit qualifier and the quantity

Package 58406-0010-04. 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 May 11, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) ( 1.1 ) Psoriatic Arthritis (PsA) ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Plaque Psoriasis (PsO) ( 1.5 ) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older ( 1.2 ) Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) ( 1.6 ) Plaque Psoriasis, 4 years of age or older ( 1.5 ) 1.1 Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely act…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 103795

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

FDA NDC Directory listings under BLA 103795
Product	Strength	Form · route	Labeler	Product NDC
Enbreletanercept	Etanercept 50 mg/mL	SolutionSubcutaneous	Immunex Corporation	58406-021
Enbreletanercept	Etanercept 50 mg/mL	SolutionSubcutaneous	Immunex Corporation	58406-032
Enbreletanercept	Etanercept 50 mg/mL	SolutionSubcutaneous	Immunex Corporation	58406-044
Enbreletanercept	Etanercept 25 mg/.5mL	SolutionSubcutaneous	Immunex Corporation	58406-055