Home NDC 70436-118 Leucovorin Calcium
Product NDC 70436-118
11-digit product format 704360118
Labeler code 70436
Product ID 70436-118_2a4aaed3-885e-bc10-e063-6294a90a61af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name leucovorin calcium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA217021
Marketing category ANDA
Marketing start 2023-07-10
Substance LEUCOVORIN CALCIUM
Active strength 200 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217021-001 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 A217021-002 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 A217021-003 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 A217021-004 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 A217021-005 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 3 · 91 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 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 91 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 200 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237788 Internal RxNorm lookup 1803930 Internal RxNorm lookup 1803932 Internal RxNorm lookup 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 70436-118-80 Leucovorin Calcium 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-118 LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] 2 Current NDC, 1 package rows 20241229_d8bdd60c-9a1c-4ef4-ba6b-b911849128f1.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 Marketing start Sample Exclude flag Status 70436-118-80 70436011880 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70436-118-80) 2023-07-10 No No Current