CAPECITABINE | A091649 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kenneth E. Surprenant FDA-2020-P-2213 · 6 docket documents Kenneth E. Surprenant filed this citizen petition requesting that the FDA revise the package inserts for Fluorouracil and Xeloda (Capecitabine) to recommend pre-treatment testing for dihydropyrimidine dehydrogenase (DPD) deficiency, shift responsibility for identifying DPD deficiency from patients t | Other | 2020-11-19 | Partially Denied | Kenneth E. Surprenant |
Citizen Petition From Ken Surprenant FDA-2014-P-0497 · 4 docket documents Ken Surprenant filed this citizen petition on April 19, 2014, requesting that the FDA revise the Warnings and Precautions section of the package insert for Xeloda (capecitabine) to include information about dihydropyrimidine dehydrogenase (DPD) deficiency as a risk factor for severe toxicity and fat | Other | 2014-04-24 | Partially Denied | Ken Surprenant |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4862
per ea
Lowest NADAC/Unit
$0.3615
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093747489CAPECITABINE 500 MG TABLET | $0.4862 | EA | Generic | — | 2026-06-17 |
| 60687014994CAPECITABINE 500 MG TABLET | $0.4862 | EA | Generic | — | 2026-06-17 |
| 00093747306CAPECITABINE 150 MG TABLET | $0.3615 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.