Leucovorin Calcium
- Product NDC
- 63323-710
- 11-digit product format
- 633230710
- Labeler code
- 63323
- Product ID
- 63323-710_2497bd71-0f85-48ec-9353-d591e1c728f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEUCOVORIN CALCIUM
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA040258
- Marketing category
- ANDA
- Marketing start
- 2010-09-18
- Substance
- LEUCOVORIN CALCIUM
- Active strength
- 200 mg/20mL
- 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 | 200 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RPR1R4C0P4 |
| Rxcui | 1803937, 2055036 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-710-50 | Leucovorin Calcium | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 5 |
| 63323-710-50 | Leucovorin Calcium | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 63323-710-59 | Leucovorin Calcium | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 63323-710-59 | Leucovorin Calcium | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEUCOVORIN CALCIUM | ACTIVE INGREDIENT | RPR1R4C0P4 | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| LEUCOVORIN | ACTIVE MOIETY | Q573I9DVLP | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| LEUCOVORIN CALCIUM | ACTIVE INGREDIENT | RPR1R4C0P4 | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| LEUCOVORIN | ACTIVE MOIETY | Q573I9DVLP | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-710 | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220312_e3b957dc-a542-4f69-b8a0-7df401ee706f.zip |
| 63323-710 | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241019_ab691d4e-e0d1-4ba1-9c7a-1cdcfcc3c17c.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 |
|---|
| 63323-710-50 | 63323071050 | 1 VIAL in 1 BOX (63323-710-50) / 20 mL in 1 VIAL | 1 vial | 2010-09-18 | 0000-00-00 | No | No | Current |
| 63323-710-59 | 63323071059 | 1 VIAL in 1 BOX (63323-710-59) / 20 mL in 1 VIAL | 1 vial | 2010-09-18 | 0000-00-00 | No | No | Current |