Hydromorphone Hydrochloride
- Product NDC
- 0703-0113
- 11-digit product format
- 007030113
- Labeler code
- 0703
- Product ID
- 0703-0113_540b835a-db66-417c-8507-0c1ed05c95bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROMORPHONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Teva Parenteral Medicines, Inc.
- Application
- ANDA078591
- Marketing category
- ANDA
- Marketing start
- 2011-01-18
- 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 |
|---|
| 0703-0113-01 | Hydromorphone Hydrochloride | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 15 |
| 0703-0113-03 | Hydromorphone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROMORPHONE HYDROCHLORIDE | ACTIVE INGREDIENT | L960UP2KRW | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] | 3 | |
| HYDROMORPHONE | ACTIVE MOIETY | Q812464R06 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] | 3 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] | 3 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0703-0113 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250508_f0b78db9-a38c-41bb-8233-5e93f7f18c5c.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 |
|---|
| 0703-0113-01 | 00703011301 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 0703-0113-03 | 00703011303 | 10 VIAL in 1 CARTON (0703-0113-03) / 5 mL in 1 VIAL (0703-0113-01) | 10 vial | 2011-01-18 | 0000-00-00 | No | No | Current |