Home NDC 69315-184 LEUCOVORIN CALCIUM
Product NDC 69315-184
11-digit product format 693150184
Labeler code 69315
Product ID 69315-184_f6c54ab5-7d54-4530-955d-206903b9dcad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEUCOVORIN CALCIUM
Dosage form TABLET
Route ORAL
Labeler Leading Pharma, LLC
Application ANDA213929
Marketing category ANDA
Marketing start 2020-11-16
Substance LEUCOVORIN CALCIUM
Active strength 5 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 A213929-001 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 A213929-002 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 A213929-003 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 A213929-004 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22
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 · 144 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 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213929-001 LEUCOVORIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213929-002 LEUCOVORIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213929-003 LEUCOVORIN CALCIUM EQ 15MG BASE TABLET / ORAL AB 2020-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213929-004 LEUCOVORIN CALCIUM EQ 25MG BASE TABLET / ORAL AB 2020-10-22 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 144 observed states.
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 5 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 69315-184-01 2023-09-11 Leucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only 69315-184-01 2023-09-11 These highlights do not include all the information needed to use LEUCOVORIN CALCIUM TABLETS safely and effectively. See full prescribing information for LEUCOVORIN CALCIUM TABLETS. LEUCOVORIN CALCIUM tablets, for oral use Initial U.S. Approval: 1952 69315-184-03 2023-09-11 Leucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only 69315-184-03 2023-09-11 These highlights do not include all the information needed to use LEUCOVORIN CALCIUM TABLETS safely and effectively. See full prescribing information for LEUCOVORIN CALCIUM TABLETS. LEUCOVORIN CALCIUM tablets, for oral use Initial U.S. Approval: 1952 69315-184-01 2023-01-30 Leucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only 69315-184-01 2023-01-30 These highlights do not include all the information needed to use LEUCOVORIN CALCIUM TABLETS safely and effectively. See full prescribing information for LEUCOVORIN CALCIUM TABLETS. LEUCOVORIN CALCIUM tablets, for oral use Initial U.S. Approval: 1952 69315-184-03 2023-01-30 Leucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only 69315-184-03 2023-01-30 These highlights do not include all the information needed to use LEUCOVORIN CALCIUM TABLETS safely and effectively. See full prescribing information for LEUCOVORIN CALCIUM TABLETS. LEUCOVORIN CALCIUM tablets, for oral use Initial U.S. Approval: 1952
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69315-184-01 LEUCOVORIN CALCIUM 100 in 1 BOTTLE TABLET 100 7 69315-184-03 LEUCOVORIN CALCIUM 30 in 1 BOTTLE TABLET 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69315-184 LEUCOVORIN CALCIUM TABLET [LEADING PHARMA, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20230912_c8102043-79f2-421a-b849-94bac19007a6.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 Units Marketing start Marketing end Sample Exclude flag Status 69315-184-01 69315018401 100 TABLET in 1 BOTTLE (69315-184-01) 100 tablet 2020-11-16 0000-00-00 No No Current 69315-184-03 69315018403 30 TABLET in 1 BOTTLE (69315-184-03) 30 tablet 2020-11-16 0000-00-00 No No Current