levoleucovorin
- Product NDC
- 68083-279
- 11-digit product format
- 680830279
- Labeler code
- 68083
- Product ID
- 68083-279_c3b9daf5-c553-46af-b651-841b43b2e706
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levoleucovorin
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA210892
- Marketing category
- ANDA
- Marketing start
- 2018-09-20
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-279-01 | levoleucovorin | 1 in 1 CARTON | INJECTION | 1 | | 5 |
| 68083-279-01 | levoleucovorin | 25 mL in 1 VIAL | INJECTION | 25 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-279 | LEVOLEUCOVORIN INJECTION [GLAND PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20201203_dbb3613c-78a9-4a96-a766-17e7a9e8809b.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 |
|---|
| 68083-279-01 | 68083027901 | 1 VIAL in 1 CARTON (68083-279-01) / 25 mL in 1 VIAL | 1 vial | 2018-09-20 | 0000-00-00 | No | No | Current |