Levoleucovorin
- Product NDC
- 71288-104
- 11-digit product format
- 712880104
- Labeler code
- 71288
- Product ID
- 71288-104_a0d839ca-80eb-4061-a0c4-30e5d94af094
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levoleucovorin calcium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc
- Application
- ANDA211003
- Marketing category
- ANDA
- Marketing start
- 2019-08-22
- Substance
- LEVOLEUCOVORIN CALCIUM
- Active strength
- 50 mg/5mL
- 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 | 50 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 778XL6VBS8 |
| Rxcui | 1720760 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-104-10 | Levoleucovorin | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 7 |
| 71288-104-10 | Levoleucovorin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-104 | LEVOLEUCOVORIN (LEVOLEUCOVORIN CALCIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20221208_b4dd0e14-d42a-4581-b1f0-7ba95b50bca6.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 |
|---|
| 71288-104-10 | 71288010410 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-104-10) > 10 mL in 1 VIAL, SINGLE-DOSE | 2019-08-22 | 0000-00-00 | No | No | Current |