Hydromorphone Hydrochloride
- Product NDC
- 0409-2634
- 11-digit product format
- 004092634
- Labeler code
- 0409
- Product ID
- 0409-2634_50886ad5-eeca-4fe7-beb0-01305f92c65d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydromorphone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA078591
- Marketing category
- ANDA
- Marketing start
- 2008-07-31
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydromorphone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROMORPHONE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L960UP2KRW |
| Rxcui | 1724338, 1724340, 1724341 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-2634-01 | Hydromorphone Hydrochloride | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 25 |
| 0409-2634-05 | Hydromorphone Hydrochloride | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 25 |
| 0409-2634-10 | Hydromorphone Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 25 |
| 0409-2634-25 | Hydromorphone Hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 25 |
| 0409-2634-50 | Hydromorphone Hydrochloride | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 25 |
| 0409-2634-50 | Hydromorphone Hydrochloride | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 50 | | 25 |
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.] | 13 | |
| HYDROMORPHONE | ACTIVE MOIETY | Q812464R06 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-2634 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 24 | Current NDC, Legacy NDC, 6 package rows | 20250508_3832ede8-d3fc-455d-ecab-3b77be5869f5.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 |
|---|
| 0409-2634-01 | 00409263401 | 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10) | | 2008-08-08 | 0000-00-00 | No | No | Current |
| 0409-2634-05 | 00409263405 | 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25) | | 2008-08-07 | 0000-00-00 | No | No | Current |
| 0409-2634-10 | 00409263410 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 0409-2634-25 | 00409263425 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |
| 0409-2634-50 | 00409263450 | 1 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-50) / 50 mL in 1 VIAL, SINGLE-DOSE | | 2008-07-31 | 0000-00-00 | No | No | Current |