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FDA shortage status: Midazolam Hydrochloride Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2020-04-02. Latest FDA row update: 2026-10-01.
FDA lists 27 package records, with companies: Avet Pharmaceuticals, Inc., Fresenius Kabi USA, LLC, Gland Pharma Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., Hospira, Inc., Hospira, Inc., a Pfizer Company, Sagent Pharmaceuticals, WG Critical Care. Package NDCs: 0409-0001-25, 0409-2305-05, 0409-2305-17, 0409-2308-01, 0409-2308-02, 0409-2587-05, 0409-2596-03, 0409-2596-05, 0641-6056-10, 0641-6057-25, 0641-6059-01, 0641-6060-10, 0641-6061-25, 23155-600-41, 23155-601-41, 23155-601-42, 25021-655-02, 25021-661-10, 44567-610-10, 44567-611-10, 63323-411-10, 63323-411-12, 63323-411-25, 63323-412-02, 63323-412-10, 63323-412-25, 76045-211-20.
FDA shortage reason: Delay in shipping of the drug; Demand increase for the drug; Other
This is nationwide FDA status, not local pharmacy inventory. CiteFacts does not provide medical, treatment, substitution, or dosing advice.
FDA package and manufacturer records
| Company | Package NDC | Presentation | FDA availability field | FDA update |
|---|---|---|---|---|
| Avet Pharmaceuticals, Inc. | 23155-600-41 | Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 23155-600-41) | Limited Availability | 2026-09-01 |
| Avet Pharmaceuticals, Inc. | 23155-601-41 | Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 23155-601-41) | Available | 2026-09-01 |
| Avet Pharmaceuticals, Inc. | 23155-601-42 | Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 23155-601-42) | Available | 2026-09-01 |
| Fresenius Kabi USA, LLC | 76045-211-20 | Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2 mL (NDC 76045-211-20) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-411-10 | Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-411-10) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-411-12 | Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-411-12) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-411-25 | Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-411-25) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-412-02 | Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 63323-412-02) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-412-10 | Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 63323-412-10) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-412-25 | Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 63323-412-25) | Unavailable | 2026-09-15 |
| Gland Pharma Limited | 25021-655-02 | Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 25021-655-02) | Unavailable | 2026-07-22 |
| Gland Pharma Limited | 25021-661-10 | Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 25021-661-10) | Unavailable | 2026-07-22 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6056-10 | Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6056-10) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6057-25 | Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6057-25) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6059-01 | Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6059-01) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6060-10 | Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 0641-6060-10) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6061-25 | Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 0641-6061-25) | Available | 2026-09-18 |
| Hospira, Inc., a Pfizer Company | 0409-2308-02 | Midazolam Hydrochloride Preservative Free, Injection, 10 mg/2 mL (5 mg/mL) (NDC 0409-2308-02) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-0001-25 | Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2mL (1 mg/mL) (NDC 0409-0001-25) | Limited Availability | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2305-17 | Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2mL (1 mg/mL) (NDC 0409-2305-17) | Limited Availability | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2305-05 | Midazolam Hydrochloride Preservative Free, Injection, 5 mg/5 mL (1 mg/mL) (NDC 0409-2305-05) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2308-01 | Midazolam Hydrochloride Preservative Free, Injection, 5 mg/mL (5 mg/mL) (NDC 0409-2308-01) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2587-05 | Midazolam Hydrochloride, Injection, 10 mg/10 mL (1 mg/mL) (NDC 0409-2587-05) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2596-03 | Midazolam Hydrochloride, Injection, 25 mg/5 mL (5 mg/mL) (NDC 0409-2596-03) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2596-05 | Midazolam Hydrochloride, Injection, 50 mg/10 mL (5 mg/mL) (NDC 0409-2596-05) | Available | 2026-09-22 |
| WG Critical Care | 44567-610-10 | Midazolam In 0.9% Sodium Chloride, Injection, 1 mg/1 mL (NDC 44567-610-10) | Available | 2026-10-01 |
| WG Critical Care | 44567-611-10 | Midazolam In 0.9% Sodium Chloride, Injection, 1 mg/1 mL (NDC 44567-611-10) | Available | 2026-10-01 |
Source facts
Grouped generic ingredient: Midazolam Hydrochloride Injection · 27 package records
Therapeutic categories: Anesthesia, Neurology
Dosage forms: Injection
Routes: INTRAMUSCULAR, INTRAVENOUS
Open FDA source data · JSON · Markdown
FDA is authoritative. Source retrieved 2026-10-06T18:55:41+00:00. Derived grouping is documented in this record's derivations.