Home NDC 67457-530-35 LEUCOVORIN CALCIUM
Product NDC 67457-530
Requested package NDC 67457-530-35
11-digit product format 674570530
Labeler code 67457
Product ID 67457-530_2890b03c-dbef-4db8-8b07-c042d7765677
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEUCOVORIN CALCIUM
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA203800
Marketing category ANDA
Marketing start 2019-01-02
Substance LEUCOVORIN CALCIUM
Active strength 350 mg/17.5mL
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 129 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 2026-09-14 22:38:34 2026-08 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203800-002 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203800-003 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203800-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2017-05-19 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 350 mg/17.5mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237788 Internal RxNorm lookup 1803932 Internal RxNorm lookup 1803937 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 67457-530-35 LEUCOVORIN CALCIUM 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 67457-530-35 LEUCOVORIN CALCIUM 17.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 17.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-530 LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [MYLAN INSTITUTIONAL LLC] 4 Current NDC, Legacy NDC, 2 package rows 20230105_1cb701ca-2478-4268-9d69-80293965d59d.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 Marketing end Sample Exclude flag Status 67457-530-35 67457053035 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-530-35) / 17.5 mL in 1 VIAL, SINGLE-DOSE 2019-01-02 0000-00-00 No No Current