Hydromorphone Hydrochloride
- Product NDC
- 0409-3365
- 11-digit product format
- 004093365
- Labeler code
- 0409
- Product ID
- 0409-3365_a3ebafac-648e-47b1-a6f5-1e3bff1e3e08
- 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
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydromorphone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROMORPHONE HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L960UP2KRW |
| Rxcui | 897653, 897753, 897756, 897757, 897758, 1724276, 1724383, 1724644 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-3365-01 | Hydromorphone Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 33 |
| 0409-3365-10 | Hydromorphone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 33 |
| 0409-3365-11 | Hydromorphone Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 33 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| 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#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-3365 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 30 | Current NDC, Legacy NDC, 3 package rows | 20241206_e9c9ef18-7dfc-4322-b2fc-29b934c30f8b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-3365-01 | 00409336501 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3365-01) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-3365-11) | | 2011-12-01 | 2022-08-01 | No | No | Current |
| 0409-3365-10 | 00409336510 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3365-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3365-11) | | 2021-06-14 | 0000-00-00 | No | No | Current |
| 0409-3365-11 | 00409336511 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |