MIDAZOLAM HYDROCHLORIDE | A075857 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mapi USA, Inc FDA-2018-P-1678 · 6 docket documents Mapi USA, Inc. filed this citizen petition under section 505(j)(2)(C) and 21 C.F.R. §314.93 requesting FDA permission to submit an ANDA for Midazolam Injection USP 1 mg/mL in a new 100 mL flexible plastic container presentation for intravenous use in intensive care settings, differing from the refer | Other | 2018-05-01 | Denied | Mapi USA, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.15
per ml
Lowest NADAC/Unit
$0.5651
per ml
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00409230849MIDAZOLAM HCL 5 MG/ML VIAL | $1.15 | ML | Generic | — | 2026-06-17 |
| 00409230801MIDAZOLAM HCL 5 MG/ML VIAL | $1.15 | ML | Generic | — | 2026-06-17 |
| 00409230850MIDAZOLAM HCL 10 MG/2 ML VIAL | $0.5651 | ML | Generic | — | 2026-06-17 |
| 00409230802MIDAZOLAM HCL 10 MG/2 ML VIAL | $0.5651 | 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.