Nalbuphine Hydrochloride
- Product NDC
- 0404-9767
- 11-digit product format
- 004049767
- Labeler code
- 0404
- Product ID
- 0404-9767_c5a5987e-4bb8-4ff2-b111-0b62911ca8e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nalbuphine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL
- Labeler
- Henry Schein, Inc.
- Application
- ANDA216049
- Marketing category
- ANDA
- Marketing start
- 2025-12-11
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nalbuphine Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 0404-9767-10 | Nalbuphine Hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 2 |
| 0404-9767-10 | Nalbuphine Hydrochloride | 1 in 1 BAG | INJECTION | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9767-10 | 00404976710 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9767-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2025-12-11 | No | No | Current |