Leucovorin calcium
- Product NDC
- 63323-631
- 11-digit product format
- 633230631
- Labeler code
- 63323
- Product ID
- 63323-631_a0d41f71-6197-4c9a-8cd2-217945cb722b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leucovorin calcium
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA207226
- Marketing category
- ANDA
- Marketing start
- 2018-07-27
- Substance
- LEUCOVORIN CALCIUM
- Active strength
- 10 mg/mL
- 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 |
|---|---|
| LEUCOVORIN CALCIUM | 10 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | RPR1R4C0P4 |
| Rxcui | 2099993, 2104714 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 31adef49-84cb-4c51-b122-69e924e10ea3 | Product name | 4 | 20240827 |
| df40773e-fe5a-474c-8d32-d19c7094e396 | Product name | 2 | 20240813 |
| cd1aa5b9-18a7-4dc4-8a13-b5c677c859a2 | Product name | 1 | 20231116 |
| 38866763-6a8e-4096-95c3-082a000c243d | Product name | 1 | 20230809 |
| 7ce39568-aceb-b33a-23ed-c4964cdcf486 | Product name | 2 | 20210211 |
| 6c712ad1-eecf-448f-84d9-5c0c307a7112 | Product name | 1 | 20161130 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-631-10 | Leucovorin calcium | 10 mL in 1 VIAL, SINGLE-USE | INJECTION | 10 | 7 | |
| 63323-631-10 | Leucovorin calcium | 1 in 1 CARTON | INJECTION | 1 | 7 | |
| 63323-631-50 | Leucovorin calcium | 50 mL in 1 VIAL, SINGLE-USE | INJECTION | 50 | 7 | |
| 63323-631-50 | Leucovorin calcium | 1 in 1 CARTON | INJECTION | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-631-10 | ML - Milliliter | 63323-631 | 0e3ba9d7-99dc-4a7d-afa7-6830472d3014 | 1 | 2018-12-13 |
| 63323-631-50 | ML - Milliliter | 63323-631 | 6e44d0cb-ecb4-4da0-92c2-b6a2849d61a2 | 1 | 2018-12-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-631 | LEUCOVORIN CALCIUM INJECTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241019_4b72d1fd-f389-45d9-b43b-510b45c92263.zip |
| 63323-631 | LEUCOVORIN CALCIUM INJECTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241031_d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2099993 | leucovorin 100 MG in 10 ML Injection | PSN | 4b72d1fd-f389-45d9-b43b-510b45c92263 | 7 |
| 2099993 | leucovorin 100 MG in 10 ML Injection | PSN | d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee | 7 |
| 2104714 | leucovorin 500 MG in 50 ML Injection | PSN | 4b72d1fd-f389-45d9-b43b-510b45c92263 | 7 |
| 2104714 | leucovorin 500 MG in 50 ML Injection | PSN | d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee | 7 |
| 2099993 | 10 ML leucovorin 10 MG/ML Injection | SCD | 4b72d1fd-f389-45d9-b43b-510b45c92263 | 7 |
| 2099993 | 10 ML leucovorin 10 MG/ML Injection | SCD | d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee | 7 |
| 2104714 | 50 ML leucovorin 10 MG/ML Injection | SCD | 4b72d1fd-f389-45d9-b43b-510b45c92263 | 7 |
| 2104714 | 50 ML leucovorin 10 MG/ML Injection | SCD | d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee | 7 |
| 2099993 | leucovorin (as leucovorin calcium) 100 MG per 10 ML Injection | SY | 4b72d1fd-f389-45d9-b43b-510b45c92263 | 7 |
| 2099993 | leucovorin (as leucovorin calcium) 100 MG per 10 ML Injection | SY | d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee | 7 |
| 2104714 | leucovorin (as leucovorin calcium) 500 MG per 50 ML Injection | SY | 4b72d1fd-f389-45d9-b43b-510b45c92263 | 7 |
| 2104714 | leucovorin (as leucovorin calcium) 500 MG per 50 ML Injection | SY | d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee | 7 |
| 2099993 | leucovorin 100 MG per 10 ML Injection | SY | 4b72d1fd-f389-45d9-b43b-510b45c92263 | 7 |
| 2099993 | leucovorin 100 MG per 10 ML Injection | SY | d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee | 7 |
| 2104714 | leucovorin 500 MG per 50 ML Injection | SY | 4b72d1fd-f389-45d9-b43b-510b45c92263 | 7 |
| 2104714 | leucovorin 500 MG per 50 ML Injection | SY | d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63323-631-10 | 63323063110 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-631-10) / 10 mL in 1 VIAL, SINGLE-USE | 2017-01-31 | 0000-00-00 | No | No | Current |
| 63323-631-50 | 63323063150 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-631-50) / 50 mL in 1 VIAL, SINGLE-USE | 2018-07-27 | 0000-00-00 | No | No | Current |