Prescription drug · BLA
Enbrel (etanercept) NDC 58406-021
Etanercept 50 mg/mL · Solution · Subcutaneous · Immunex Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58406-021-04 | 58406002104 | 4 SYRINGE in 1 CARTON (58406-021-04) / 1 mL in 1 SYRINGE (58406-021-01)Marketed from Jun 7, 2019 | |
| 58406-021-96 | 58406002196 | 1 SYRINGE in 1 CARTON (58406-021-96) / 1 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 — 50 mg/mL
- Dosage form
- Solution
- Route
- Subcutaneous
- Labeler
- Immunex Corporation
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103795
- Marketing start
- Listing expires
- Other FDA classes
- Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
- Identifiers
- Product ID 58406-021_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.
- NDC on a medical claim
N458406002104followed by a unit qualifier and the quantityPackage 58406-0021-04. 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 . 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.
Other NDCs under BLA 103795
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 |
|---|---|---|---|---|
| Enbreletanercept | Etanercept 25 mg/.5mL | SolutionSubcutaneous | Immunex Corporation | 58406-010 |
| 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 |