Hydromorphone Hydrochloride
- Product NDC
- 0409-2540
- 11-digit product format
- 004092540
- Labeler code
- 0409
- Product ID
- 0409-2540_637c38f4-ec91-464c-aaed-34243c12cb33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROMORPHONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- NDA200403
- Marketing category
- NDA
- Marketing start
- 2011-12-01
- Marketing end
- 0000-00-00
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 4 mg/mL
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c92985da-a658-b186-e763-2287eda87a86 | Product name | 3 | 20250221 |
| 96c475b3-58c7-b955-d715-0111804a3e50 | Product name | 5 | 20210512 |
| 1dd54659-b775-4fa8-a858-7f0e521fbadc | Product name | 4 | 20200925 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0409-2540-01 | Hydromorphone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 33 | |
| 0409-2540-11 | Hydromorphone Hydrochloride | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | 33 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-2540-01 | ML - Milliliter | 0409-2540 | 5c1d41c9-c8ee-4073-ac70-f9d50e8a4f5d | 1 | 2012-07-24 |
| 0409-2540-11 | ML - Milliliter | 0409-2540 | f120fe8c-097b-495a-881a-e9c516cc4fb6 | 1 | 2017-07-07 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | ACTIVE INGREDIENT | L960UP2KRW | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| HYDROMORPHONE | ACTIVE MOIETY | Q812464R06 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| LACTIC ACID, UNSPECIFIED FORM | INACTIVE INGREDIENT | 33X04XA5AT | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM LACTATE | INACTIVE INGREDIENT | TU7HW0W0QT | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1724383 | HYDROmorphone HCl 1 MG in 1 ML Cartridge | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897653 | HYDROmorphone HCl 1 MG in 1 ML Injection | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897756 | HYDROmorphone HCl 1 MG in 1 ML Prefilled Syringe | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724644 | HYDROmorphone HCl 2 MG in 1 ML Cartridge | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724276 | HYDROmorphone HCl 2 MG in 1 ML Injection | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897757 | HYDROmorphone HCl 2 MG in 1 ML Prefilled Syringe | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897758 | HYDROmorphone HCl 4 MG in 1 ML Cartridge | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897753 | HYDROmorphone HCl 4 MG in 1 ML Injection | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724383 | 1 ML hydromorphone hydrochloride 1 MG/ML Cartridge | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897653 | 1 ML hydromorphone hydrochloride 1 MG/ML Injection | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897756 | 1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724644 | 1 ML hydromorphone hydrochloride 2 MG/ML Cartridge | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724276 | 1 ML hydromorphone hydrochloride 2 MG/ML Injection | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897757 | 1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897758 | 1 ML hydromorphone hydrochloride 4 MG/ML Cartridge | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897753 | 1 ML hydromorphone hydrochloride 4 MG/ML Injection | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724383 | hydromorphone HCl 1 MG per 1 ML Cartridge | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897653 | hydromorphone HCl 1 MG per 1 ML Injection | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897756 | hydromorphone HCl 1 MG per 1 ML Prefilled Syringe | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724644 | hydromorphone HCl 2 MG per 1 ML Cartridge | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724276 | hydromorphone HCl 2 MG per 1 ML Injection | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897757 | hydromorphone HCl 2 MG per 1 ML Prefilled Syringe | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897758 | hydromorphone HCl 4 MG per 1 ML Cartridge | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897753 | hydromorphone HCl 4 MG per 1 ML Injection | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 0409-2540-01 | 00409254001 | 10 in 1 CARTON | Historical | |
| 0409-2540-11 | 00409254011 | 1 mL in 1 AMPULE | 1 ml | Historical |