Home NDC 0143-9558 Levoleucovorin
Product NDC 0143-9558
11-digit product format 001439558
Labeler code 0143
Product ID 0143-9558_d5427bbc-8598-4e79-9aeb-b0a9317e3433
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levoleucovorin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA206263
Marketing category ANDA
Marketing start 2016-07-07
Substance LEVOLEUCOVORIN CALCIUM
Active strength 50 mg/5mL
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 A206263-001 LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16
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 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS 2016-06-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206263-001 LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS AP 2016-06-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Levoleucovorin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOLEUCOVORIN CALCIUM 50 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 778XL6VBS8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1720760 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 0143-9558-01 Levoleucovorin 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 8 0143-9558-01 Levoleucovorin 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9558 LEVOLEUCOVORIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 8 Current NDC, Legacy NDC, 2 package rows 20210430_54f01988-aac2-4b0e-9d20-b7f621a0cd50.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 0143-9558-01 00143955801 1 VIAL in 1 BOX (0143-9558-01) / 5 mL in 1 VIAL 1 vial 2016-07-07 0000-00-00 No No Current