LEUCOVORIN CALCIUM
- Product NDC
- 69315-184
- 11-digit product format
- 693150184
- Labeler code
- 69315
- Product ID
- 69315-184_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
- 5 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 | 5 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 |
|---|
| 69315-184-01 | 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 |
| 69315-184-03 | 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 |
| 69315-184-01 | 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 |
| 69315-184-03 | 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 |
|---|
| 69315-184-01 | LEUCOVORIN CALCIUM | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 69315-184-03 | LEUCOVORIN CALCIUM | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-184 | 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 |
|---|
| 69315-184-01 | 69315018401 | 100 TABLET in 1 BOTTLE (69315-184-01) | 100 tablet | 2020-11-16 | 0000-00-00 | No | No | Current |
| 69315-184-03 | 69315018403 | 30 TABLET in 1 BOTTLE (69315-184-03) | 30 tablet | 2020-11-16 | 0000-00-00 | No | No | Current |