NALBUPHINE HCI
- Product NDC
- 51662-1418
- 11-digit product format
- 516621418
- Labeler code
- 51662
- Product ID
- 51662-1418_2b37c24d-1ab8-34d6-e063-6294a90abf70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALBUPHINE HCI
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA070918
- Marketing category
- ANDA
- Marketing start
- 2019-10-29
- 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 HCI
- 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 | 904440 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1418-1 | NALBUPHINE HCI | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 4 |
| 51662-1418-1 | NALBUPHINE HCI | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1418 | NALBUPHINE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250110_96128b54-24d6-88a3-e053-2a95a90a1c9c.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 |
|---|
| 51662-1418-1 | 51662141801 | 1 VIAL, MULTI-DOSE in 1 CARTON (51662-1418-1) / 10 mL in 1 VIAL, MULTI-DOSE | 2019-10-29 | 0000-00-00 | No | No | Current |