Nalbuphine hydrochloride
- Product NDC
- 70069-662
- 11-digit product format
- 700690662
- Labeler code
- 70069
- Product ID
- 70069-662_d4c32b91-24cf-43f2-a1d2-0120f31bbba8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nalbuphine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA216049
- Marketing category
- ANDA
- Marketing start
- 2024-09-26
- Substance
- NALBUPHINE HYDROCHLORIDE
- Active strength
- 20 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZU4275277R |
| Rxcui | 904415, 904440 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-662-10 | Nalbuphine hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 70069-662-10 | Nalbuphine hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-662 | NALBUPHINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC] | 1 | Current NDC, 2 package rows | 20240927_d82dafac-cce7-445a-8127-2a10b6d947ca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-662-10 | 70069066210 | 1 VIAL, MULTI-DOSE in 1 CARTON (70069-662-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2024-09-26 | No | No | Current |