CEFDINIR | A065332 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2013-P-0947 · 4 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate an additional Reference Listed Drug for Cefdinir for Oral Suspension in the Orange Book, because the original RLD (OMN | 505(q) | 2013-09-16 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1253
per ml
Lowest NADAC/Unit
$0.0983
per ml
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093413764CEFDINIR 250 MG/5 ML SUSP | $0.1253 | ML | Generic | — | 2026-06-17 |
| 00093413773CEFDINIR 250 MG/5 ML SUSP | $0.1210 | ML | Generic | — | 2026-06-17 |
| 00093413664CEFDINIR 125 MG/5 ML SUSP | $0.1168 | ML | Generic | — | 2026-06-17 |
| 00093413673CEFDINIR 125 MG/5 ML SUSP | $0.0983 | ML | 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.