Prescription drug · NDA
Tagrisso (Osimertinib) NDC 0310-1251
Osimertinib 80 mg/1 · Tablet, Film coated · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-1251-30 | 00310125130 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-1251-30)Marketed from Feb 21, 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)
- Tagrisso
- Generic name (nonproprietary)
- osimertinib
- Active ingredients
- Osimertinib — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208065
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0310-1251_bc71de23-ee63-49b7-8b0e-97e5e8a52d05SPL ID bc71de23-ee63-49b7-8b0e-97e5e8a52d05
- 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
N400310125130followed by a unit qualifier and the quantityPackage 00310-1251-30. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0310-1251
- What is NDC 0310-1251?
- 0310-1251 is the product NDC for Tagrisso (osimertinib), Osimertinib 80 mg/1 tablet, film coated, 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?
- Tagrisso (Osimertinib).
- What is the active ingredient?
- Osimertinib.
- 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 Tagrisso?
- 3 other product NDCs are listed under this name. See all Tagrisso NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tagrisso products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tagrissoosimertinib | Osimertinib 40 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-1248 | 00310-1248-30 |
| Tagrissoosimertinib | Osimertinib 40 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-1349 | 00310-1349-30 |
| Tagrissoosimertinib | Osimertinib 80 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-1350 | 00310-1350-3000310-1350-99 |
Other NDCs under NDA 208065
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 |
|---|---|---|---|---|
| Tagrissoosimertinib | Osimertinib 40 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-1248 |
| Tagrissoosimertinib | Osimertinib 40 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-1349 |
| Tagrissoosimertinib | Osimertinib 80 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-1350 |