NDC 0409-1312 – Hydromorphone Hydrochloride
Hydromorphone Hydrochloride 2 mg/mL · Injection, Solution · Intramuscular, Intravenous, Subcutaneous
Product NDC0409-1312
Product details
- Brand name
- Hydromorphone Hydrochloride
- Generic name
- Hydromorphone Hydrochloride
- Labeler
- Hospira, Inc.
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Marketing category
- NDA · NDA200403
- Marketed since
- February 1, 2021
- Listing expires
- December 31, 2027
- Pharmacologic class
- Opioid Agonist
Active ingredients
- Hydromorphone Hydrochloride 2 mg/mL
Uses, dosage, side effects and warnings for Hydromorphone Hydrochloride →
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0409-1312-30 | 10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03) | Dec 1, 2011 |
| 0409-1312-36 | 10 SYRINGE in 1 CELLO PACK (0409-1312-36) / 1 mL in 1 SYRINGE (0409-1312-16) | Feb 1, 2021 |
Recalls mentioning this NDC
- D-1167-2017 Sep 27, 2017 · Class II
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. - D-020-2013 Oct 31, 2012 · Class I
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume. - D-1444-2012 Aug 15, 2012 · Class I
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Other Hydromorphone Hydrochloride products
- 63323-854 Hydromorphone Hydrochloride 4 mg/mL · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-852 Hydromorphone Hydrochloride 1 mg/mL · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-851 Hydromorphone Hydrochloride 10 mg/mL · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-853 Hydromorphone Hydrochloride 2 mg/mL · Injection, Solution · Fresenius Kabi USA, LLC
- 0641-6254 Hydromorphone Hydrochloride 2 mg/mL · Injection, Solution · Hikma Pharmaceuticals USA Inc.
- 0409-1283 Hydromorphone Hydrochloride 1 mg/mL · Injection, Solution · Hospira, Inc.
- 0409-1304 Hydromorphone Hydrochloride 4 mg/mL · Injection, Solution · Hospira, Inc.
- 0409-1805 Hydromorphone Hydrochloride .25 mg/.5mL · Injection, Solution · Hospira, Inc.
- 0409-2634 Hydromorphone Hydrochloride 10 mg/mL · Injection, Solution · Hospira, Inc.
- 0409-3365 Hydromorphone Hydrochloride 2 mg/mL · Injection, Solution · Hospira, Inc.
- 0409-4264 Hydromorphone Hydrochloride .5 mg/.5mL · Injection, Solution · Hospira, Inc.
- 0703-0113 Hydromorphone Hydrochloride 10 mg/mL · Injection, Solution · Teva Parenteral Medicines, Inc.