Prescription drug · NDA
Vizimpro (Dacomitinib) NDC 0069-0197
Dacomitinib 15 mg/1 · Tablet, Film coated · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0197-30 | 00069019730 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-0197-30)Marketed from Oct 4, 2018 |
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)
- Vizimpro
- Generic name (nonproprietary)
- dacomitinib
- Active ingredients
- Dacomitinib — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211288
- Marketing start
- Marketing end
- Identifiers
- Product ID 0069-0197_3ffd0da1-5601-4ecc-a8fb-f484693cb4c5SPL ID 3ffd0da1-5601-4ecc-a8fb-f484693cb4c5SPL set ID 4ab27d2f-e385-4e9c-b324-fa69c10b855aRxCUI 2058915, 2058922, 2058924, 2058926, 2058930, 2058932UNII 5092U85G58UPC 0300691198308, 0300692299301, 0300690197302
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
N400069019730followed by a unit qualifier and the quantityPackage 00069-0197-30. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0069-0197
- What is NDC 0069-0197?
- 0069-0197 is the product NDC for Vizimpro (dacomitinib), Dacomitinib 15 mg/1 tablet, film coated, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vizimpro (Dacomitinib).
- What is the active ingredient?
- Dacomitinib.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vizimpro?
- 2 other product NDCs are listed under this name. See all Vizimpro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vizimpro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vizimprodacomitinib | Dacomitinib 30 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-1198 | 00069-1198-30 |
| Vizimprodacomitinib | Dacomitinib 45 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-2299 | 00069-2299-30 |
Other NDCs under NDA 211288
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 |
|---|---|---|---|---|
| Vizimprodacomitinib | Dacomitinib 30 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-1198 |
| Vizimprodacomitinib | Dacomitinib 45 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-2299 |