Levoleucovorin
- Product NDC
- 0143-9558
- 11-digit product format
- 001439558
- Labeler code
- 0143
- Product ID
- 0143-9558_d5427bbc-8598-4e79-9aeb-b0a9317e3433
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levoleucovorin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA206263
- Marketing category
- ANDA
- Marketing start
- 2016-07-07
- 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 |
|---|
| 0143-9558-01 | Levoleucovorin | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 8 |
| 0143-9558-01 | Levoleucovorin | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9558 | LEVOLEUCOVORIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20210430_54f01988-aac2-4b0e-9d20-b7f621a0cd50.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 |
|---|
| 0143-9558-01 | 00143955801 | 1 VIAL in 1 BOX (0143-9558-01) / 5 mL in 1 VIAL | 1 vial | 2016-07-07 | 0000-00-00 | No | No | Current |