Prescription drug · NDA
Koselugo (Selumetinib) NDC 0310-0635
Selumetinib 5 mg/1 · Granule · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-0635-60 | 0031006356000310063560 | 60 GRANULE in 1 BOTTLE (0310-0635-60)Marketed from Sep 10, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Koselugo
- Generic name (nonproprietary)
- selumetinib
- Active ingredients
- Selumetinib — 5 mg/1
- Dosage form
- Granule
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219943
- Marketing start
- Listing expires
- Other FDA classes
- Mitogen-Activated Protein Kinase Kinase 1 Inhibitors (Mechanism)Mitogen-Activated Protein Kinase Kinase 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 0310-0635_bdebc47d-8420-42eb-aaa7-b243dc9e42b2SPL ID bdebc47d-8420-42eb-aaa7-b243dc9e42b2SPL set ID 7d042c61-f28f-4ab5-ab10-d7558c0d49ffRxCUI 2289418, 2289424, 2289426, 2289428, 2723653, 2723657, 2723659, 2723661UNII 6UH91I579U
- Pharmacologic class
- Kinase Inhibitor
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400310063560followed by a unit qualifier and the quantityPackage 00310-0635-60. 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)
KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0310-0635
- What is NDC 0310-0635?
- 0310-0635 is the product NDC for Koselugo (selumetinib), Selumetinib 5 mg/1 granule, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Koselugo (Selumetinib).
- What is the active ingredient?
- Selumetinib.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Koselugo?
- 3 other product NDCs are listed under this name. See all Koselugo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Koselugo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Koselugoselumetinib | Selumetinib 7.5 mg/1 | GranuleOral | AstraZeneca Pharmaceuticals LP | 0310-0640 | 00310-0640-60 |
| Koselugoselumetinib | Selumetinib 10 mg/1 | CapsuleOral | AstraZeneca Pharmaceuticals LP | 0310-0610 | 00310-0610-2800310-0610-60 |
| Koselugoselumetinib | Selumetinib 25 mg/1 | CapsuleOral | AstraZeneca Pharmaceuticals LP | 0310-0625 | 00310-0625-2800310-0625-60 |
Other NDCs under NDA 219943
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 |
|---|---|---|---|---|
| Koselugoselumetinib | Selumetinib 7.5 mg/1 | GranuleOral | AstraZeneca Pharmaceuticals LP | 0310-0640 |