Home NDC 0054-4497 Leucovorin Calcium
Product NDC 0054-4497
11-digit product format 000544497
Labeler code 0054
Product ID 0054-4497_3ea4147c-f529-42ad-8672-4d36ab4c2b37
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leucovorin Calcium
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA072734
Marketing category ANDA
Marketing start 1993-02-22
Substance LEUCOVORIN CALCIUM
Active strength 10 mg/1
Pharmacologic classes Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A072734-001 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072734-001 AB
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 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL 1993-02-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL 1993-02-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL 1993-02-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL 1993-02-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072734-001 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 1993-02-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Leucovorin Calcium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEUCOVORIN CALCIUM 10 mg/1
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197860 Internal RxNorm lookup 197861 Internal RxNorm lookup 197862 Internal RxNorm lookup 197863 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 0054-4497-05 Leucovorin Calcium 12 in 1 BOTTLE TABLET 12 11 0054-4497-10 Leucovorin Calcium 24 in 1 BOTTLE TABLET 24 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEUCOVORIN CALCIUM ACTIVE INGREDIENT RPR1R4C0P4 LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] 6 LEUCOVORIN ACTIVE MOIETY Q573I9DVLP LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-4497 LEUCOVORIN CALCIUM TABLET [HIKMA PHARMACEUTICALS USA INC.] 10 Current NDC, Legacy NDC, 2 package rows 20231215_33663425-4731-4977-9127-9e59b6b91497.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 0054-4497-05 00054449705 12 TABLET in 1 BOTTLE (0054-4497-05) 12 tablet 1993-03-22 0000-00-00 No No Current 0054-4497-10 00054449710 24 TABLET in 1 BOTTLE (0054-4497-10) 24 tablet 1993-03-22 0000-00-00 No No Current