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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| RPR1R4C0P4 | LEUCOVORIN CALCIUM | 1492-18-8 | LEUCOVORIN CALCIUM |
Packages
| 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 | Historical |