CEFDINIR | A065259 | LUPIN LTD
| 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 | WithdrawnUnverified summary | — |
Citizen Petition from Lupin Pharmaceuticals, Inc. FDA-2006-P-0013 · 7 docket documents Lupin Pharmaceuticals, Inc. filed this suitability petition pursuant to 21 CFR 314.93 and section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cefdinir Chewable Tablets in strengths of 187.5 mg, 250 mg, and 300 mg suitable for submission as an abbreviated | Other | 2008-08-14 | WithdrawnUnverified summary | Lupin Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1195
per ml
Lowest NADAC/Unit
$0.1063
per ml
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 68180072304CEFDINIR 250 MG/5 ML SUSP | $0.1195 | ML | Generic | — | 2026-08-19 |
| 68180072305CEFDINIR 250 MG/5 ML SUSP | $0.1135 | ML | Generic | — | 2026-08-19 |
| 68180072204CEFDINIR 125 MG/5 ML SUSP | $0.1133 | ML | Generic | — | 2026-08-19 |
| 68180072205CEFDINIR 125 MG/5 ML SUSP | $0.1063 | ML | Generic | — | 2026-08-19 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.