CARVEDILOL | A076373 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Reference 1 Package insert for Coreg re Suitability Petition from Emprise Pha... FDA-2020-P-2166 · 8 docket documents Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co, Ltd, filed a suitability petition regarding the reference package insert for Coreg, seeking FDA confirmation that the reference product's labeling is appropriate for use in developing an abbreviated new drug application or generic equivale | Suitability | 2020-11-05 | Withdrawn | New Time Pharmaceutical Co, Ltd |
Citizen Petition from Keller And Heckman LLP FDA-2007-P-0058 · 11 docket documents Keller and Heckman LLP filed this suitability petition under Section 505(j)(2)(C) requesting FDA approval to file an ANDA for carvedilol phosphate in extended-release tablet form, which would differ from the reference listed drug Coreg CR (carvedilol phosphate extended-release capsules) only in dosa | Other | 2008-07-10 | Withdrawn | Keller And Heckman LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0320
per ea
Lowest NADAC/Unit
$0.0170
per ea
Brand NDCs
0
Generic NDCs
8
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093729601CARVEDILOL 25 MG TABLET | $0.0320 | EA | Generic | — | 2026-06-17 |
| 00093729605CARVEDILOL 25 MG TABLET | $0.0320 | EA | Generic | — | 2026-06-17 |
| 00093729501CARVEDILOL 12.5 MG TABLET | $0.0209 | EA | Generic | — | 2026-06-17 |
| 00093729505CARVEDILOL 12.5 MG TABLET | $0.0209 | EA | Generic | — | 2026-06-17 |
| 00093013505CARVEDILOL 6.25 MG TABLET | $0.0184 | EA | Generic | — | 2026-06-17 |
| 00093013501CARVEDILOL 6.25 MG TABLET | $0.0184 | EA | Generic | — | 2026-06-17 |
| 00093005101CARVEDILOL 3.125 MG TABLET | $0.0170 | EA | Generic | — | 2026-06-17 |
| 00093005105CARVEDILOL 3.125 MG TABLET | $0.0170 | 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.