Butorphanol Tartrate
- Product NDC
- 0054-3090
- 11-digit product format
- 000543090
- Labeler code
- 0054
- Product ID
- 0054-3090_57de4cd2-a163-4ac7-9e86-a04355a00d78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butorphanol Tartrate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA075824
- Marketing category
- ANDA
- Marketing start
- 2002-03-12
- Substance
- BUTORPHANOL TARTRATE
- Active strength
- 10 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2L7I72RUHN |
| Rxcui | 886634 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-3090-36 | Butorphanol Tartrate | 1 in 1 CONTAINER | SPRAY, METERED | 1 | | 20 |
| 0054-3090-36 | Butorphanol Tartrate | 2.5 mL in 1 BOTTLE, SPRAY | SPRAY, METERED | 2.5 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUTORPHANOL TARTRATE | ACTIVE INGREDIENT | 2L7I72RUHN | BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] | 4 | |
| BUTORPHANOL | ACTIVE MOIETY | QV897JC36D | BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] | 4 | |
| BENZETHONIUM CHLORIDE | INACTIVE INGREDIENT | PH41D05744 | BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] | 4 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-3090 | BUTORPHANOL TARTRATE SPRAY, METERED [HIKMA PHARMACEUTICALS USA INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250327_5a50d22e-acbe-4b15-9ed6-70713378408a.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 |
|---|
| 0054-3090-36 | 00054309036 | 1 BOTTLE, SPRAY in 1 CONTAINER (0054-3090-36) / 2.5 mL in 1 BOTTLE, SPRAY | 2002-03-12 | 0000-00-00 | No | No | Current |