Leucovorin Calcium
- Product NDC
- 0054-4497
- 11-digit product format
- 000544497
- Labeler code
- 0054
- Product ID
- 0054-4497_3ea4147c-f529-42ad-8672-4d36ab4c2b37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leucovorin Calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA072734
- Marketing category
- ANDA
- Marketing start
- 1993-02-22
- Substance
- LEUCOVORIN CALCIUM
- Active strength
- 10 mg/1
- Pharmacologic classes
- Folate Analog [EPC], Folic Acid [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Leucovorin Calcium
- Listing expiration
- 2027-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-4497-05 | Leucovorin Calcium | 12 in 1 BOTTLE | TABLET | 12 | | 11 |
| 0054-4497-10 | Leucovorin Calcium | 24 in 1 BOTTLE | TABLET | 24 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEUCOVORIN CALCIUM | ACTIVE INGREDIENT | RPR1R4C0P4 | LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] | 6 | |
| LEUCOVORIN | ACTIVE MOIETY | Q573I9DVLP | LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] | 6 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-4497 | LEUCOVORIN CALCIUM TABLET [HIKMA PHARMACEUTICALS USA INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20231215_33663425-4731-4977-9127-9e59b6b91497.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 |
|---|
| 0054-4497-05 | 00054449705 | 12 TABLET in 1 BOTTLE (0054-4497-05) | 12 tablet | 1993-03-22 | 0000-00-00 | No | No | Current |
| 0054-4497-10 | 00054449710 | 24 TABLET in 1 BOTTLE (0054-4497-10) | 24 tablet | 1993-03-22 | 0000-00-00 | No | No | Current |