Prescription drug · BLA
Adalimumab-aacf (Adalimumab) NDC 65219-612
Kit · Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-612-69 | 65219061269 | 2 CARTON in 1 CARTON (65219-612-69) / 1 KIT in 1 CARTON * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95)Marketed from Sep 30, 2024 | |
| 65219-612-89 | 65219061289 | 3 CARTON in 1 CARTON (65219-612-89) / 1 KIT in 1 CARTON * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95)Marketed from Sep 30, 2024 | |
| 65219-612-99 | 65219061299 | 1 KIT in 1 CARTON (65219-612-99) * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95)Marketed from Dec 6, 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)
- Adalimumab-aacf
- Generic name (nonproprietary)
- adalimumab
- Dosage form
- Kit
- Route
- Subcutaneous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761255
- Marketing start
- Listing expires
- Identifiers
- Product ID 65219-612_ed59e023-eb91-482f-a1fe-19a31c0906c2SPL ID ed59e023-eb91-482f-a1fe-19a31c0906c2SPL set ID 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915RxCUI 797544, 2640851, 2640859, 2640864, 2640869UPC 0365219618027, 0365219610021
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
N465219061269followed by a unit qualifier and the quantityPackage 65219-0612-69. 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)
Adalimumab-aacf 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. Juvenile 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. Ankylosing Spondylitis (AS) ( 1.4 ): reducing sign…
Excerpt only. Read the full label for complete information.
About NDC 65219-612
- What is NDC 65219-612?
- 65219-612 is the product NDC for Adalimumab-aacf (adalimumab) kit, listed with the FDA by Fresenius Kabi USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adalimumab-aacf (Adalimumab).
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Adalimumab-aacf?
- 1 other product NDC are listed under this name. See all Adalimumab-aacf NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Adalimumab-aacf products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Adalimumab-aacfadalimumab | — | KitSubcutaneous | Fresenius Kabi USA, LLC | 65219-620 | 65219-0620-20 |
Other NDCs under BLA 761255
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-aacfadalimumab | — | KitSubcutaneous | Fresenius Kabi USA, LLC | 65219-620 |
| Idacioadalimumab-aacf | — | KitSubcutaneous | Fresenius Kabi USA, LLC | 65219-554 |
| Idacioadalimumab-aacf | — | Kit | Fresenius Kabi USA, LLC | 65219-558 |