Leucovorin Calcium
- Product NDC
- 68083-587
- 11-digit product format
- 680830587
- Labeler code
- 68083
- Product ID
- 68083-587_0ac32e99-c204-4104-8d83-4a24c0baccf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leucovorin Calcium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA218200
- Marketing category
- ANDA
- Marketing start
- 2025-11-12
- Substance
- LEUCOVORIN CALCIUM
- Active strength
- 350 mg/17.5mL
- 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
- Leucovorin Calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEUCOVORIN CALCIUM | 350 mg/17.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RPR1R4C0P4 |
| Rxcui | 237788 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-587-01 | Leucovorin Calcium | 17.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 17.5 | | 4 |
| 68083-587-01 | Leucovorin Calcium | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-587-01 | 68083058701 | 1 VIAL in 1 CARTON (68083-587-01) / 17.5 mL in 1 VIAL | 1 vial | 2025-11-12 | No | No | Current |