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FDA shortage status: Hydromorphone Hydrochloride Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2017-10-31. Latest FDA row update: 2026-10-01.
FDA lists 26 package records, with companies: Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., Hospira, Inc., Hospira, Inc., a Pfizer Company, Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc.. Package NDCs: 0409-1283-31, 0409-1283-37, 0409-1304-31, 0409-1312-30, 0409-1312-36, 0409-1805-01, 0409-2634-01, 0409-2634-05, 0409-2634-50, 0409-3365-10, 0409-4264-01, 0641-0121-25, 0641-6254-01, 0703-0018-01, 0703-0110-03, 0703-0113-03, 63323-851-10, 63323-851-15, 63323-851-50, 63323-852-25, 63323-853-25, 63323-854-10, 76045-009-06, 76045-009-11, 76045-010-11, 76045-121-11.
FDA shortage reason: 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 |
|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 76045-121-11 | Dilaudid, Injection, .2 mg/1 mL (NDC 76045-121-11) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 76045-009-06 | Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-06) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 76045-009-11 | Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-11) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 76045-010-11 | Dilaudid, Injection, 2 mg/1 mL (NDC 76045-010-11) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-852-25 | Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-852-25) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-851-10 | Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-10) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-851-15 | Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-15) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-851-50 | Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-50) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-853-25 | Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 63323-853-25) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-854-10 | Hydromorphone Hydrochloride, Injection, 4 mg/1 mL (NDC 63323-854-10) | Available | 2026-09-15 |
| Hikma Pharmaceuticals USA, Inc. | 0641-0121-25 | Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0641-0121-25) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6254-01 | Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0641-6254-01) | Unavailable | 2026-09-18 |
| Hospira, Inc., a Pfizer Company | 0409-1805-01 | Hydromorphone Hydrochloride, Injection, 0.25 mg/ 0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-1805-01) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-4264-01 | Hydromorphone Hydrochloride, Injection, 0.5 mg/0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-4264-01) | Limited Availability | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1283-37 | Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 0409-1283-37) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1283-31 | Hydromorphone Hydrochloride, Injection, 1 mg/1 mL Syringes (NDC 0409-1283-31) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2634-01 | Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0409-2634-01) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1312-36 | Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-1312-36) | Limited Availability | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-3365-10 | Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-3365-10) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1312-30 | Hydromorphone Hydrochloride, Injection, 2 mg/1 mL Syringes (NDC 0409-1312-30) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1304-31 | Hydromorphone Hydrochloride, Injection, 4 mg/1 mL Syringes (NDC 0409-1304-31) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2634-05 | Hydromorphone Hydrochloride, Injection, 50 mg/5 mL (10 mg/mL) (NDC 0409-2634-05) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2634-50 | Hydromorphone Hydrochloride, Injection, 500 mg/50 mL (10 mg/mL) (NDC 0409-2634-50) | Available | 2026-09-22 |
| Teva Pharmaceuticals USA, Inc. | 0703-0018-01 | Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0018-01) | Available | 2026-10-01 |
| Teva Pharmaceuticals USA, Inc. | 0703-0110-03 | Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0110-03) | Available | 2026-10-01 |
| Teva Pharmaceuticals USA, Inc. | 0703-0113-03 | Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0113-03) | Limited Availability | 2026-10-01 |
Source facts
Grouped generic ingredient: Hydromorphone Hydrochloride Injection · 26 package records
Therapeutic categories: Analgesia/Addiction
Dosage forms: Injection
Routes: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
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.