Leucovorin Calcium
- Product NDC
- 25021-816
- 11-digit product format
- 250210816
- Labeler code
- 25021
- Product ID
- 25021-816_ff2ba160-e2f9-4ab9-9e67-2409f02c923e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leucovorin calcium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA200855
- Marketing category
- ANDA
- Marketing start
- 2012-09-15
- 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, 1803930, 1803932, 1803937 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-816-30 | Leucovorin Calcium | 17.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 17.5 | | 9 |
| 25021-816-30 | Leucovorin Calcium | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| leucovorin calcium | ACTIVE INGREDIENT | RPR1R4C0P4 | LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| leucovorin | ACTIVE MOIETY | Q573I9DVLP | LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-816 | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 9 | Current NDC, Legacy NDC, 2 package rows | 20221201_9d0e5356-ff39-4a8e-944c-e808a21ef4b2.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 |
|---|
| 25021-816-30 | 25021081630 | 1 VIAL in 1 CARTON (25021-816-30) / 17.5 mL in 1 VIAL | 1 vial | 2012-09-15 | 0000-00-00 | No | No | Current |
| 25021-816-67 | 25021081667 | 1 VIAL in 1 CARTON (25021-816-67) > 17.5 mL in 1 VIAL | 1 vial | 2013-12-01 | 2022-01-31 | No | No | Current |