Nalbuphine Hydrochloride
- Product NDC
- 0409-1464
- 11-digit product format
- 004091464
- Labeler code
- 0409
- Product ID
- 0409-1464_cbcbf107-67c0-4a8a-a25d-5a05c43a0bfd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALBUPHINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA070915
- Marketing category
- ANDA
- Marketing start
- 2005-07-19
- 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 | 904415, 904440, 1866543, 1866551 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-1464-01 | Nalbuphine Hydrochloride | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 34 |
| 0409-1464-61 | Nalbuphine Hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 34 |
| 0409-1464-61 | Nalbuphine Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 34 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NALBUPHINE HYDROCHLORIDE | ACTIVE INGREDIENT | ZU4275277R | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| NALBUPHINE | ACTIVE MOIETY | L2T84IQI2K | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-1464 | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 33 | Current NDC, Legacy NDC, 3 package rows | 20241207_6025e8d4-5083-4c3a-58a0-050e7b0b6150.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 |
|---|
| 0409-1464-01 | 00409146401 | 25 CARTON in 1 CASE (0409-1464-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1464-61) / 10 mL in 1 VIAL, MULTI-DOSE | 25 carton | 2005-07-19 | 0000-00-00 | No | No | Current |
| 0409-1464-61 | 00409146461 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |