LEUCOVORIN CALCIUM
- Product NDC
- 67457-529
- 11-digit product format
- 674570529
- Labeler code
- 67457
- Product ID
- 67457-529_2890b03c-dbef-4db8-8b07-c042d7765677
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEUCOVORIN CALCIUM
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA203800
- Marketing category
- ANDA
- Marketing start
- 2019-07-23
- Substance
- LEUCOVORIN CALCIUM
- Active strength
- 200 mg/20mL
- Pharmacologic classes
- Folate Analog [EPC], Folic Acid [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | |
| A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | |
| A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203800-001 | AP |
| A203800-002 | AP |
| A203800-003 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203800-002 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203800-003 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203800-001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2017-05-19 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203800-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203800-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203800-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203800-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203800-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203800-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203800-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203800-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203800-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203800-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203800-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203800-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203800-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203800-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203800-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203800-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203800-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203800-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203800-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203800-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203800-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203800-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203800-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203800-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203800-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203800-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203800-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203800-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203800-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203800-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203800-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203800-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203800-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203800-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203800-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203800-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203800-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203800-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203800-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203800-001 | AP | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEUCOVORIN CALCIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEUCOVORIN CALCIUM | 200 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RPR1R4C0P4 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1cb701ca-2478-4268-9d69-80293965d59d | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67457-529-20 | LEUCOVORIN CALCIUM | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | 4 | |
| 67457-529-20 | LEUCOVORIN CALCIUM | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67457-529-20 | EA - Each | 67457-529 | aaaece57-b682-4d47-b6d5-df2d782e917a | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | Mylan Institutional LLC | 1cb701ca-2478-4268-9d69-80293965d59d | 2022-06-01 | Warnings, Adverse reactions | 203800 ANDA203800 67457-529 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1803932 | leucovorin 100 MG Injection | PSN | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
| 1803937 | leucovorin 200 MG Injection | PSN | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
| 237788 | leucovorin 350 MG Injection | PSN | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
| 1803932 | leucovorin 100 MG Injection | SCD | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
| 1803937 | leucovorin 200 MG Injection | SCD | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
| 237788 | leucovorin 350 MG Injection | SCD | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
| 1803932 | leucovorin (as leucovorin calcium) 100 MG Injection | SY | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
| 1803937 | leucovorin (as leucovorin calcium) 200 MG Injection | SY | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
| 237788 | leucovorin (as leucovorin calcium) 350 MG Injection | SY | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
| 237788 | leucovorin 350 MG per 17.5 ML Lyophilized Powder for Injection | SY | 1cb701ca-2478-4268-9d69-80293965d59d | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67457-529-20 | 67457052920 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-529-20) / 20 mL in 1 VIAL, SINGLE-DOSE | 2019-07-23 | 0000-00-00 | No | No | Current |