Leucovorin Calcium
- Product NDC
- 70436-119
- 11-digit product format
- 704360119
- Labeler code
- 70436
- Product ID
- 70436-119_2a4aaed3-885e-bc10-e063-6294a90a61af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leucovorin calcium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA217021
- Marketing category
- ANDA
- Marketing start
- 2024-12-27
- Substance
- LEUCOVORIN CALCIUM
- Active strength
- 350 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RPR1R4C0P4 |
| Rxcui | 237788, 1803930, 1803932, 1803937, 2055036 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-119-80 | Leucovorin Calcium | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-119 | LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] | 2 | Current NDC, 1 package rows | 20241229_d8bdd60c-9a1c-4ef4-ba6b-b911849128f1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70436-119-80 | 70436011980 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70436-119-80) | 2024-12-27 | No | No | Current |