Levoleucovorin
- Product NDC
- 71288-105
- 11-digit product format
- 712880105
- Labeler code
- 71288
- Product ID
- 71288-105_17100790-fb82-43cd-80eb-b3e73d918bbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levoleucovorin calcium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA211002
- Marketing category
- ANDA
- Marketing start
- 2019-08-16
- Substance
- LEVOLEUCOVORIN CALCIUM
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Folate Analog [EPC], Folic Acid [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levoleucovorin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOLEUCOVORIN CALCIUM | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 778XL6VBS8 |
| Rxcui | 1720765, 1720773 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-105-18 | Levoleucovorin | 17.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 17.5 | | 9 |
| 71288-105-18 | Levoleucovorin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
| 71288-105-25 | Levoleucovorin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
| 71288-105-25 | Levoleucovorin | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-105 | LEVOLEUCOVORIN (LEVOLEUCOVORIN CALCIUM) INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240110_059a3306-6207-497f-a947-33198f18761f.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 |
|---|
| 71288-105-18 | 71288010518 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-18) / 17.5 mL in 1 VIAL, SINGLE-DOSE | 2019-08-16 | 0000-00-00 | No | No | Current |
| 71288-105-25 | 71288010525 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25) / 25 mL in 1 VIAL, SINGLE-DOSE | 2019-08-16 | 0000-00-00 | No | No | Current |