Home NDC 63323-711 Leucovorin Calcium
Product NDC 63323-711
11-digit product format 633230711
Labeler code 63323
Product ID 63323-711_2497bd71-0f85-48ec-9353-d591e1c728f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEUCOVORIN CALCIUM
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA040286
Marketing category ANDA
Marketing start 2010-09-18
Substance LEUCOVORIN CALCIUM
Active strength 500 mg/50mL
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 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040286-001 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.
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 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040286-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1999-02-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 500 mg/50mL
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 1803937 Internal RxNorm lookup 2055036 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 63323-711-00 Leucovorin Calcium 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 5 63323-711-00 Leucovorin Calcium 50 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 50 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEUCOVORIN CALCIUM ACTIVE INGREDIENT RPR1R4C0P4 LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 LEUCOVORIN ACTIVE MOIETY Q573I9DVLP LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-711 LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20220312_e3b957dc-a542-4f69-b8a0-7df401ee706f.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 · 1 matching rows.
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 63323-711-00 63323071100 1 VIAL in 1 BOX (63323-711-00) / 50 mL in 1 VIAL 1 vial 2010-09-18 0000-00-00 No No Current