Levorphanol Tartrate
- Product NDC
- 57664-058
- 11-digit product format
- 576640058
- Labeler code
- 57664
- Product ID
- 57664-058_48471dc2-bdd9-2263-e063-6294a90a9e03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levorphanol Tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA213906
- Marketing category
- ANDA
- Marketing start
- 2024-06-15
- Substance
- LEVORPHANOL TARTRATE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levorphanol Tartrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVORPHANOL TARTRATE | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04WQU6T9QI |
| Rxcui | 197873, 2058845 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57664-058-88 | Levorphanol Tartrate | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-058 | LEVORPHANOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 9 | Current NDC, 1 package rows | 20240831_438cf3ea-04fe-4626-9f0f-adcda7633651.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57664-058-88 | 57664005888 | 100 TABLET in 1 BOTTLE (57664-058-88) | 100 tablet | 2024-06-15 | No | No | Historical |