Leucovorin Calcium

Product NDC
0703-5145
11-digit product format
007035145
Labeler code
0703
Product ID
0703-5145_dd032f1a-b2f3-44bc-bce2-9fa72470a6a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA040174
Marketing category
ANDA
Marketing start
2013-05-13
Marketing end
0000-00-00
Substance
LEUCOVORIN CALCIUM
Active strength
350 mg/17.5mL
Pharmacologic classes
Folate Analog [EPC],Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0703-5145DDiscontinued by firm2026-08-11
excluded productproduct0703-5145DDiscontinued by firm2026-08-11
excluded packagepackage0703-51450703-5145-01DDiscontinued by firm2026-08-11
excluded packagepackage0703-51450703-5145-91DDiscontinued by firm2026-08-11

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0703-5145-91d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0703-5145-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0703-5145-91f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0703-5145-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0703-5145-912ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0703-5145-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0703-5145-91a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0703-5145-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0703-5145-91cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0703-5145-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0703-5145-91cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0703-5145-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0703-5145-91302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0703-5145-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0703-5145-91ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0703-5145-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0703-5145-910efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0703-5145-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0703-5145-91ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0703-5145-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0703-5145-91367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0703-5145-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0703-5145-91557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0703-5145-01557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040174-001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-12

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-123f01610625f2…
2019-09-15 20:21 UTC2019-09A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTION1997-06-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040174-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP1997-06-12cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040174-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040174-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040174-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040174-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040174-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040174-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040174-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040174-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040174-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040174-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040174-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040174-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040174-001AP1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040174-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040174-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040174-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040174-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040174-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040174-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040174-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040174-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040174-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040174-001AP1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-5145-01EA - Each0703-514504b714c5-a4f9-46e7-a2c7-39834f9d3cb812012-07-24
0703-5145-91EA - Each0703-5145bf9f6e04-f9a6-485e-b4b9-6f673f9af92812013-06-04

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-5145-01007035145011 VIAL, SINGLE-USE in 1 CARTON (0703-5145-01) > 17.5 mL in 1 VIAL, SINGLE-USE1997-06-120000-00-00NoNoCurrent
0703-5145-91007035145911 VIAL, SINGLE-USE in 1 CARTON (0703-5145-91) > 17.5 mL in 1 VIAL, SINGLE-USE2013-05-130000-00-00NoNoCurrent