Nalbuphine Hydrochloride
- Product NDC
- 0409-1463
- 11-digit product format
- 004091463
- Labeler code
- 0409
- Product ID
- 0409-1463_88e18ca7-8688-4646-94f9-f4a153cd19a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALBUPHINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA070914
- Marketing category
- ANDA
- Marketing start
- 2008-06-27
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nalbuphine Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 0409-1463-01 | Nalbuphine Hydrochloride | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 34 |
| 0409-1463-71 | Nalbuphine Hydrochloride | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | | 34 |
| 0409-1463-49 | Nalbuphine Hydrochloride | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 22 |
| 0409-1463-69 | Nalbuphine Hydrochloride | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | | 22 |
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 | |
| NALBUPHINE HYDROCHLORIDE | ACTIVE INGREDIENT | ZU4275277R | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| NALBUPHINE | ACTIVE MOIETY | L2T84IQI2K | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-1463 | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 33 | Current NDC, Legacy NDC, 2 package rows | 20241207_6025e8d4-5083-4c3a-58a0-050e7b0b6150.zip |
| 0409-1463 | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20241207_a99fe500-f52b-483c-807c-178f1a78a02b.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 |
|---|
| 0409-1463-01 | 00409146301 | 10 AMPULE in 1 TRAY (0409-1463-01) / 1 mL in 1 AMPULE (0409-1463-71) | 10 ampule | 2005-03-31 | 0000-00-00 | No | No | Current |
| 0409-1463-49 | 00409146349 | 10 AMPULE in 1 TRAY (0409-1463-49) / 1 mL in 1 AMPULE (0409-1463-69) | 10 ampule | 2008-06-27 | 0000-00-00 | No | No | Current |
| 0409-1463-69 | 00409146369 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |
| 0409-1463-71 | 00409146371 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |