NALBUPHINE HCI
- Product NDC
- 51662-1420
- 11-digit product format
- 516621420
- Labeler code
- 51662
- Product ID
- 51662-1420_2b37c789-d5da-dc83-e063-6294a90a4ca5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALBUPHINE HCI
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA070915
- Marketing category
- ANDA
- Marketing start
- 2019-10-29
- 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 HCI
- 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 |
|---|
| 51662-1420-1 | NALBUPHINE HCI | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 3 |
| 51662-1420-1 | NALBUPHINE HCI | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1420 | NALBUPHINE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250110_96139914-0708-7b58-e053-2995a90a7308.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1420-1 | 51662142001 | 1 VIAL, MULTI-DOSE in 1 CARTON (51662-1420-1) / 10 mL in 1 VIAL, MULTI-DOSE | 2019-10-29 | 0000-00-00 | No | No | Current |