LEUCOVORIN CALCIUM
- Product NDC
- 67457-530
- 11-digit product format
- 674570530
- Labeler code
- 67457
- Product ID
- 67457-530_2890b03c-dbef-4db8-8b07-c042d7765677
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEUCOVORIN CALCIUM
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA203800
- Marketing category
- ANDA
- Marketing start
- 2019-01-02
- 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, 1803932, 1803937 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-530-35 | LEUCOVORIN CALCIUM | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 67457-530-35 | LEUCOVORIN CALCIUM | 17.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 17.5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-530 | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [MYLAN INSTITUTIONAL LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230105_1cb701ca-2478-4268-9d69-80293965d59d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-530-35 | 67457053035 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-530-35) / 17.5 mL in 1 VIAL, SINGLE-DOSE | 2019-01-02 | 0000-00-00 | No | No | Current |