Home NDC 68001-286-38 Leucovorin
Product NDC 68001-286
Requested package NDC 68001-286-38
11-digit product format 680010286
Labeler code 68001
Product ID 68001-286_f73c5c51-46ca-4669-8b7e-f76d964e6696
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leucovorin Calcium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler BluePoint Laboratories
Application ANDA200855
Marketing category ANDA
Marketing start 2016-07-01
Marketing end 0000-00-00
Substance LEUCOVORIN CALCIUM
Active strength 20 mg/mL
Pharmacologic classes Folate Analog [EPC],Folic Acid [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200855-001 AP
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 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68001-286-38 68001028638 1 VIAL in 1 CARTON (68001-286-38) > 17.5 mL in 1 VIAL (68001-286-39) 1 vial 2016-07-01 0000-00-00 No No Current