CLARITHROMYCIN | A065489 | AUROBINDO PHARMA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Xiromed, LLC on behalf of LifePharma FZE FDA-2017-P-5205 · 4 docket documents Xiromed, LLC filed this petition on behalf of LifePharma FZE requesting that the FDA designate ANDA 065489 held by Aurobindo Pharma LTD as a Reference Standard for clarithromycin tablets 250 mg and 300 mg, since the original Reference Listed Drug BIAXIN (NDA 050662) held by Abbvie has been discontin | 505(q) | 2017-08-25 | Open | LifePharma FZE |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4639
per ea
Lowest NADAC/Unit
$0.3421
per ea
Brand NDCs
0
Generic NDCs
7
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50268017913CLARITHROMYCIN 500 MG TABLET | $0.4639 | EA | Generic | — | 2026-06-17 |
| 57237004560CLARITHROMYCIN 500 MG TABLET | $0.4639 | EA | Generic | — | 2026-06-17 |
| 00904687204CLARITHROMYCIN 500 MG TABLET | $0.4639 | EA | Generic | — | 2026-06-17 |
| 65862022660CLARITHROMYCIN 500 MG TABLET | $0.4639 | EA | Generic | — | 2026-06-17 |
| 65862022560CLARITHROMYCIN 250 MG TABLET | $0.3421 | EA | Generic | — | 2026-06-17 |
| 50268017815CLARITHROMYCIN 250 MG TABLET | $0.3421 | EA | Generic | — | 2026-06-17 |
| 57237004460CLARITHROMYCIN 250 MG TABLET | $0.3421 | 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.