CEFTRIAXONE SODIUM | A065169 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Bentley Biomedical Consulting, LLC FDA-2020-P-1873 · 3 docket documents Bentley Biomedical Consulting, LLC filed this petition under 21 CFR Part 10 requesting that the FDA Commissioner designate Sandoz Ceftriaxone (Application Number 065169) as the reference listed drug for ANDA 211841 for Ceftriaxone, since the original RLD Roche Ceftriaxone (Rocephin) has been discont | Other | 2020-09-14 | Withdrawn | Bentley Biomedical Consulting, LLC |
Citizen Petition from Samson Medical Technologies, L.L.C. FDA-2005-P-0380 · 7 docket documents Samson Medical Technologies, L.L.C. filed a citizen petition on March 21, 2005, pursuant to 21 CFR 314.93 and section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting permission to file an Abbreviated New Drug Application for Ceftriaxone for Injection, USP, in a 100 gram pharmacy | Other | 2017-08-29 | Granted | Samson Medical Technologies, L.L.C. |
Citizen Petition from Hospira Inc. FDA-2011-P-0059 · 4 docket documents Hospira Inc. filed this citizen petition pursuant to FDC Act Section 505(j)(2)(C) and 21 CFR 314.93 requesting that FDA designate Sandoz's Ceftriaxone for Injection 1g and 2g in ADD-Vantage Vial (ANDA 065204) as an additional Reference Listed Drug so that generic applicants may submit ANDAs citing t | 505(q) | 2011-01-27 | Granted | Hospira Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$3.45
per ea
Lowest NADAC/Unit
$0.8622
per ea
Brand NDCs
0
Generic NDCs
14
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00781320885CEFTRIAXONE 1 GM VIAL | $3.45 | EA | Generic | — | 2025-09-17 |
| 00409733503CEFTRIAXONE 2 GM VIAL | $2.56 | EA | Generic | — | 2026-06-17 |
| 00409733520CEFTRIAXONE 2 GM VIAL | $2.56 | EA | Generic | — | 2026-06-17 |
| 00781320995CEFTRIAXONE 2 GM VIAL | $2.56 | EA | Generic | — | 2026-06-17 |
| 00781320785CEFTRIAXONE 500 MG VIAL | $1.84 | EA | Generic | — | 2026-06-17 |
| 00781320895CEFTRIAXONE 1 GM VIAL | $1.29 | EA | Generic | — | 2026-06-17 |
Showing 6 of 14 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.