Butorphanol Tartrate
- Product NDC
- 0409-1626
- 11-digit product format
- 004091626
- Labeler code
- 0409
- Product ID
- 0409-1626_280bcddf-00c7-4c78-a108-f86ce2d30f41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butorphanol Tartrate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA074626
- Marketing category
- ANDA
- Marketing start
- 2005-12-20
- Substance
- BUTORPHANOL TARTRATE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Butorphanol Tartrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUTORPHANOL TARTRATE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2L7I72RUHN |
| Rxcui | 886627, 1728351, 1728355 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-1626-01 | Butorphanol Tartrate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 28 |
| 0409-1626-02 | Butorphanol Tartrate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 28 |
| 0409-1626-21 | Butorphanol Tartrate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 28 |
| 0409-1626-42 | Butorphanol Tartrate | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 28 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUTORPHANOL TARTRATE | ACTIVE INGREDIENT | 2L7I72RUHN | BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| BUTORPHANOL | ACTIVE MOIETY | QV897JC36D | BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-1626 | BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] | 27 | Current NDC, Legacy NDC, 4 package rows | 20250130_9822ca3f-aee2-46e5-8a96-495400e65d10.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 |
|---|
| 0409-1626-01 | 00409162601 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-21) | | 2006-03-17 | 0000-00-00 | No | No | Current |
| 0409-1626-02 | 00409162602 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-1626-42) | | 2005-12-20 | 0000-00-00 | No | No | Current |
| 0409-1626-10 | 00409162610 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-10) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-09) | | 2016-02-11 | 2021-04-01 | No | No | Current |
| 0409-1626-21 | 00409162621 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 0409-1626-42 | 00409162642 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |