Home NDC 63323-631 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207226-001 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27
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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table 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 A207226-001 LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207226-001 LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207226-001 LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207226-001 LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207226-001 LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207226-001 LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207226-001 LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207226-001 LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207226-001 LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RS 2018-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION RS 2018-07-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207226-001 LEUCOVORIN CALCIUM EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-07-27 cb3db0bc1861…
Observed Orange Book normalized TE history# 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/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RPR1R4C0P4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2099993 Internal RxNorm lookup 2104714 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table 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
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.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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