Prescription drug · BLA
Simlandi (adalimumab-ryvk) NDC 51759-523
Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51759-523-21 | 51759052321 | 1 KIT in 1 CARTON (51759-523-21) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (51759-634-31) * .4 mL in 1 POUCH (65517-0002-1)Marketed from Jan 29, 2025 |
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)
- Simlandi
- Generic name (nonproprietary)
- adalimumab-ryvk
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761299
- Marketing start
- Listing expires
- Identifiers
- Product ID 51759-523_021cc6a0-a2e6-4e30-95dc-065c64b7fe70SPL ID 021cc6a0-a2e6-4e30-95dc-065c64b7fe70SPL set ID 12f609c9-2088-bb05-e063-6394a90a9eccRxCUI 797544, 2677780, 2677787, 2688819, 2688823, 2688826, 2688827, 2688828, 2688829, 2706644, 2706645
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
N451759052321followed by a unit qualifier and the quantityPackage 51759-0523-21. 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)
SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for: 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 rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761299
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 |
|---|---|---|---|---|
| Adalimumab-ryvk | — | Kit | Teva Pharmaceuticals USA, Inc. | 51759-310 |
| Simlandiadalimumab-ryvk | — | KitSubcutaneous | Teva Pharmaceuticals USA, Inc. | 51759-274 |
| Adalimumab-ryvk | — | Kit | Teva Pharmaceuticals USA, Inc. | 51759-311 |
| Adalimumab-ryvk | — | Kit | Teva Pharmaceuticals USA, Inc. | 51759-360 |
| Adalimumab-ryvk | — | Kit | Teva Pharmaceuticals USA, Inc. | 51759-361 |
| Simlandiadalimumab-ryvk | — | Kit | Teva Pharmaceuticals USA, Inc. | 51759-412 |
| Simlandiadalimumab-ryvk | — | Kit | Teva Pharmaceuticals USA, Inc. | 51759-386 |
| Simlandiadalimumab-ryvk | — | KitSubcutaneous | Teva Pharmaceuticals USA, Inc. | 51759-402 |
| Simlandiadalimumab-ryvk | — | KitSubcutaneous | A-S Medication Solutions | 50090-7718 |
| Adalimumab-ryvk | — | KitSubcutaneous | Quallent Pharmaceuticals Health LLC | 82009-156 |
| Adalimumab-ryvk | — | KitSubcutaneous | Quallent Pharmaceuticals Health LLC | 82009-158 |