LEUCOVORIN CALCIUM
- Product NDC
- 69315-185
- 11-digit product format
- 693150185
- Labeler code
- 69315
- Product ID
- 69315-185_f6c54ab5-7d54-4530-955d-206903b9dcad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEUCOVORIN CALCIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA213929
- Marketing category
- ANDA
- Marketing start
- 2020-11-16
- Substance
- LEUCOVORIN CALCIUM
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RPR1R4C0P4 |
| Rxcui | 197860, 197861, 197862, 197863 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 69315-185-12 | 2023-09-11 | C162847 | 48780-1 | f386c649-e01c-0266-e053-dadaa90a7c1a | Leucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only |
| 69315-185-24 | 2023-09-11 | C162847 | 48780-1 | f386c649-e01c-0266-e053-dadaa90a7c1a | Leucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only |
| 69315-185-12 | 2023-01-30 | C162847 | 48780-1 | f386c649-e01c-0266-e053-dadaa90a7c1a | Leucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only |
| 69315-185-24 | 2023-01-30 | C162847 | 48780-1 | f386c649-e01c-0266-e053-dadaa90a7c1a | Leucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-185-12 | LEUCOVORIN CALCIUM | 12 in 1 BOTTLE | TABLET | 12 | | 7 |
| 69315-185-24 | LEUCOVORIN CALCIUM | 24 in 1 BOTTLE | TABLET | 24 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-185 | LEUCOVORIN CALCIUM TABLET [LEADING PHARMA, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230912_c8102043-79f2-421a-b849-94bac19007a6.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 |
|---|
| 69315-185-12 | 69315018512 | 12 TABLET in 1 BOTTLE (69315-185-12) | 12 tablet | 2020-11-16 | 0000-00-00 | No | No | Current |
| 69315-185-24 | 69315018524 | 24 TABLET in 1 BOTTLE (69315-185-24) | 24 tablet | 2020-11-16 | 0000-00-00 | No | No | Current |