Nalbuphine Hydrochloride
- Product NDC
- 84549-464
- 11-digit product format
- 845490464
- Labeler code
- 84549
- Product ID
- 84549-464_463cff7e-0486-7c6d-e063-6294a90ae0e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALBUPHINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA070915
- Marketing category
- ANDA
- Marketing start
- 2005-07-19
- Substance
- NALBUPHINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nalbuphine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALBUPHINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZU4275277R |
| Rxcui | 904415 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84549-464-01 | Nalbuphine Hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-464-01 | 84549046401 | 10 mL in 1 VIAL, MULTI-DOSE (84549-464-01) | 10 ml | 2025-08-27 | No | No | Current |