Home NDC 42806-133 Leucovorin Calcium
Product NDC 42806-133
11-digit product format 428060133
Labeler code 42806
Product ID 42806-133_9db189e6-7ecc-465c-8197-c454350a45dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leucovorin Calcium
Dosage form TABLET
Route ORAL
Labeler Epic Pharma LLC
Application ANDA074544
Marketing category ANDA
Marketing start 2021-01-01
Substance LEUCOVORIN CALCIUM
Active strength 10 mg/1
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074544-001 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 A074544-002 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 A074544-003 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 A074544-004 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 4 · 148 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 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074544-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 1997-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074544-002 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 1997-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074544-003 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074544-004 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2021-05-19 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 140 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 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 42806-133-21 Leucovorin Calcium 12 in 1 BOTTLE TABLET 12 7 42806-133-24 Leucovorin Calcium 24 in 1 BOTTLE TABLET 24 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-133 LEUCOVORIN CALCIUM TABLET [EPIC PHARMA LLC] 7 Current NDC, Legacy NDC, 2 package rows 20231221_2627a485-05b5-4dab-ac20-dc840e5c469d.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 42806-133-21 42806013321 12 TABLET in 1 BOTTLE (42806-133-21) 12 tablet 2021-01-01 0000-00-00 No No Current 42806-133-24 42806013324 24 TABLET in 1 BOTTLE (42806-133-24) 24 tablet 2021-01-01 0000-00-00 No No Current