OMEPRAZOLE MAGNESIUM | N022056 | AZURITY PHARMACEUTICALS SWITZERLAND GMBH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Proctor & Gamble Company - Citizen Petition FDA-2013-P-1286 · 3 docket documents Procter & Gamble Company filed this citizen petition requesting that the FDA continue requiring consistent labeling across all over-the-counter proton pump inhibitors approved for frequent heartburn treatment, substantially equivalent to that approved for Prilosec OTC, including statements about del | 505(q) | 2013-11-14 | Denied | — |
Public Citizens Health Research Group - Citizen Petition FDA-2011-P-0741 · 4 docket documents Public Citizen's Health Research Group filed this citizen petition pursuant to 21 U.S.C. § 352 and 21 C.F.R. §§ 10.30 and 201.56 requesting that the FDA immediately add black box warnings and other enhanced safety labeling to all proton pump inhibitors including Nexium, Dexilant, Prilosec, Zegerid, | Other | 2011-10-20 | Partially Denied | — |
Mattingly, Stanger & Malur, P.C. - Citizen Petition FDA-2003-P-0224 · 4 docket documents The law firm Mattingly, Stanger & Malur, P.C. filed this citizen petition under 21 CFR 10.30 and 10.35(b) requesting that the FDA amend its NDA approval for Prilosec OTC (omeprazole magnesium), a nonprescription heartburn treatment approved on June 20, 2003, to require marketing under a different br | Other | 2009-01-05 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$14.78
per ea
Lowest NADAC/Unit
$14.72
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70515061001PRILOSEC DR 10 MG SUSPENSION | $14.78 | EA | Brand | — | 2026-06-17 |
| 70515062501PRILOSEC DR 2.5 MG SUSPENSION | $14.72 | EA | Brand | — | 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.