Leucovorin Calcium
- Product NDC
- 0143-9368
- 11-digit product format
- 001439368
- Labeler code
- 0143
- Product ID
- 0143-9368_0000f768-a8cc-46ba-95a1-88b0ebd09be7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leucovorin Calcium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA040056
- Marketing category
- ANDA
- Marketing start
- 1995-05-23
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9368-01 | Leucovorin Calcium | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 3 |
| 0143-9368-01 | Leucovorin Calcium | 1 in 1 BOX, UNIT-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9368 | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220630_f198ab39-9394-4280-be44-93a88264a450.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 |
|---|
| 0143-9368-01 | 00143936801 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9368-01) / 20 mL in 1 VIAL | 1 vial | 2019-10-01 | 0000-00-00 | No | No | Current |