Hydromorphone Hydrochloride
- Product NDC
- 0641-6151
- 11-digit product format
- 006416151
- Labeler code
- 0641
- Product ID
- 0641-6151_4c244852-0374-445f-8419-72e8ec359faa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydromorphone Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA202159
- Marketing category
- ANDA
- Marketing start
- 2018-07-01
- 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 | 1724276 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6151-01 | Hydromorphone Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 8 |
| 0641-6151-25 | Hydromorphone Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6151 | HYDROMORPHONE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240410_67e79859-4efc-4ea7-8211-cadf746bc864.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 |
|---|
| 0641-6151-01 | 00641615101 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 0641-6151-25 | 00641615125 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6151-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6151-01) | | 2018-07-01 | 0000-00-00 | No | No | Current |