Prescription drug · BLA
Imuldosa (Ustekinumab-srlf) NDC 69448-017
Ustekinumab-srlf 45 mg/.5mL · Injection · Subcutaneous · Accord BioPharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69448-017-63 | 6944800176369448001763 | 1 BLISTER PACK in 1 CARTON (69448-017-63) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGEMarketed from Oct 14, 2024 |
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)
- Imuldosa
- Generic name (nonproprietary)
- ustekinumab-srlf
- Active ingredients
- Ustekinumab-srlf — 45 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Accord BioPharma Inc.NDC labeler code 69448
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761364
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
- Identifiers
- Product ID 69448-017_be75347b-ab5d-4104-b90e-7c7b1f46fbefSPL ID be75347b-ab5d-4104-b90e-7c7b1f46fbefSPL set ID 2539a6cf-0fe5-1565-e063-6294a90a3618RxCUI 2717067, 2717074, 2717078, 2717083, 2717085, 2717086UNII FU77B4U5Z0UPC 0369448017637, 0369448018634
- Pharmacologic class
- Interleukin-12 Antagonist; Interleukin-23 Antagonist
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
N469448001763followed by a unit qualifier and the quantityPackage 69448-0017-63. 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 .
Indications (excerpt from the label)
IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1) active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2) moderately to severely active Crohn’s disease in adult patients. (1.3) moderately to severely active ulcerative colitis in adult patients. (1.4) 1.1 Plaque Psoriasis (PsO) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherap…
Excerpt only. Read the full label for complete information.
About NDC 69448-017
- What is NDC 69448-017?
- 69448-017 is the product NDC for Imuldosa (ustekinumab-srlf), Ustekinumab-srlf 45 mg/.5mL injection, listed with the FDA by Accord BioPharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imuldosa (Ustekinumab-srlf).
- What is the active ingredient?
- Ustekinumab-srlf.
- Who is the labeler?
- Accord BioPharma Inc., NDC labeler code 69448. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imuldosa?
- 2 other product NDCs are listed under this name. See all Imuldosa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imuldosa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imuldosaustekinumab-srlf | Ustekinumab-srlf 130 mg/26mL | InjectionIntravenous | Accord BioPharma Inc. | 69448-019 | 69448-0019-26 |
| Imuldosaustekinumab-srlf | Ustekinumab-srlf 90 mg/mL | InjectionSubcutaneous | Accord BioPharma Inc. | 69448-018 | 69448-0018-63 |
Other NDCs under BLA 761364
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 |
|---|---|---|---|---|
| Imuldosaustekinumab-srlf | Ustekinumab-srlf 90 mg/mL | InjectionSubcutaneous | Accord BioPharma Inc. | 69448-018 |
| Imuldosaustekinumab-srlf | Ustekinumab-srlf 130 mg/26mL | InjectionIntravenous | Accord BioPharma Inc. | 69448-019 |