2/4/2024

Hydromorphone Immediate-Release Oral Presentations

Products Affected - Description

- Dilaudid oral immediate release tablet, Rhodes, 2 mg, bottle, 100 count, NDC 42858-0122-01
- Dilaudid oral immediate release tablet, Rhodes, 8 mg, bottle, 100 count, NDC 42858-0338-01
- Hydromorphone Hydrochloride oral immediate release tablet, Mallinckrodt, 2 mg, bottle, 100 count, NDC 00406-3243-01
- Hydromorphone Hydrochloride oral immediate release tablet, Mallinckrodt, 4 mg, bottle, 100 count, NDC 00406-3244-01
- Hydromorphone Hydrochloride oral immediate release tablet, Mallinckrodt, 8 mg, bottle, 100 count, NDC 00406-3249-01
- Hydromorphone Hydrochloride oral immediate release tablet, Rhodes, 2 mg, bottle, 100 count, NDC 42858-0301-01
- Hydromorphone Hydrochloride oral immediate release tablet, Rhodes, 4 mg, bottle, 100 count, NDC 42858-0302-01
- Hydromorphone Hydrochloride oral immediate release tablet, Rhodes, 8 mg, bottle, 100 count, NDC 42858-0303-01
- Hydromorphone Hydrochloride oral solution, Rhodes, 1 mg/mL, 473 mL bottle, NDC 42858-0304-16
- Hydromorphone Hydrochloride oral tablet, Rhodes, bottle, 500 count, NDC 42858-0302-50

Reason for the Shortage

- Rhodes has hydromorphone tablets on back order due to DEA quota/active ingredient exhaustion.
- Rhodes did not provide a reason for the shortage of Dilaudid oral presentations.
- Mallinckrodt is actively manufacturing hydromorphone tablets. Wholesalers may be allocating product.

Available Products

- Dilaudid oral immediate release tablet, Rhodes, 4 mg, bottle, 100 count, NDC 42858-0234-01
- Dilaudid oral immediate release tablet, Rhodes, 4 mg, bottle, 500 count, NDC 42858-0234-50
- Dilaudid oral solution, Rhodes, 1 mg/mL, 473 mL bottle, NDC 42858-0416-16
- Hydromorphone Hydrochloride oral immediate release tablet, Rhodes, 2 mg, unit-dose blister pack, 100 count, NDC 42858-0301-25
- Hydromorphone Hydrochloride oral immediate release tablet, Rhodes, 4 mg, unit-dose blister pack, 100 count, NDC 42858-0302-25

Estimated Resupply Dates

- Mallinckrodt is actively manufacturing hydromorphone tablets. Wholesalers are allocating all presentations.
- Rhodes has hydromorphone 2 mg tablets in 100 count bottles, 4 mg tablets in 100 count bottles, 4 mg tablets in 500 count bottles, 8 mg tablets in 100 count bottles, and 1 mg/mL oral solution on back order. The company cannot estimate a release date for the 4 mg tablets in 100 count bottles and 500 count bottles and the 1 mg/mL oral solution. The 2 mg tablets in 100 count bottles and 8 mg tablets in 100 count bottles are expected to release in late-March 2024.
- Rhodes has Dilaudid 2 mg tablets in 100 count bottles and 8 mg tablets in 100 count bottles on back order and the company cannot estimate a release date.

Updated

Updated February 4, 2024 by Elyse MacDonald, PharmD, MS, BCPS. Created December 15, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

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