Hydromorphone Hydrochloride
- Product NDC
- 63323-851
- 11-digit product format
- 633230851
- Labeler code
- 63323
- Product ID
- 63323-851_9e8522c6-595c-46f9-bb25-272aa4683e0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydromorphone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA019034
- Marketing category
- NDA
- Marketing start
- 2017-12-15
- 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
- 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L960UP2KRW |
| Rxcui | 897653, 897753, 1724276, 1724338, 1724340, 1724341 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-851-03 | Hydromorphone Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 6 |
| 63323-851-07 | Hydromorphone Hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 6 |
| 63323-851-10 | Hydromorphone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 6 |
| 63323-851-15 | Hydromorphone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 6 |
| 63323-851-50 | Hydromorphone Hydrochloride | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-851 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 5 package rows | 20250418_e034eb96-03e0-46e1-8b92-5e1f94555e7b.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 |
|---|
| 63323-851-03 | 63323085103 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 63323-851-07 | 63323085107 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |
| 63323-851-10 | 63323085110 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-10) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-851-03) | | 2017-12-15 | 0000-00-00 | No | No | Current |
| 63323-851-15 | 63323085115 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-15) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-851-07) | | 2017-12-15 | 0000-00-00 | No | No | Current |
| 63323-851-50 | 63323085150 | 50 mL in 1 VIAL, SINGLE-DOSE (63323-851-50) | 50 ml | 2017-12-15 | 0000-00-00 | No | No | Current |