Nalbuphine Hydrochloride
- Product NDC
- 0404-9918
- 11-digit product format
- 004049918
- Labeler code
- 0404
- Product ID
- 0404-9918_0e0e0bdd-27ee-48e6-9390-56ec6e71eccc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nalbuphine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA070914
- Marketing category
- ANDA
- Marketing start
- 2022-01-13
- 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 | 1866543 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9918-01 | Nalbuphine Hydrochloride | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 5 |
| 0404-9918-01 | Nalbuphine Hydrochloride | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9918 | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250523_596826ff-e471-4d4f-9a73-2a34e2af2dd6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9918-01 | 00404991801 | 1 AMPULE in 1 BAG (0404-9918-01) / 1 mL in 1 AMPULE | 1 ampule | 2022-01-13 | 0000-00-00 | No | No | Current |