Leucovorin Calcium

Product NDC
0904-6703
11-digit product format
009046703
Labeler code
0904
Product ID
0904-6703_17638b77-384b-4746-8626-92924e1ad9da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA072736
Marketing category
ANDA
Marketing start
1993-02-22
Marketing end
0000-00-00
Substance
LEUCOVORIN CALCIUM
Active strength
25 mg/1
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-6703DDiscontinued by firm2026-08-11
excluded packagepackage0904-67030904-6703-10DDiscontinued by firm2026-08-11

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
A072736-001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1993-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A072736-001AB

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 UTC2026-02A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-223f01610625f2…
2019-09-15 20:21 UTC2019-09A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072736-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALABRS1993-02-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A072736-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072736-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072736-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072736-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072736-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072736-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072736-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072736-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072736-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072736-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072736-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072736-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072736-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072736-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072736-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072736-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072736-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072736-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072736-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072736-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072736-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072736-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072736-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072736-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072736-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072736-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072736-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072736-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072736-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072736-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072736-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072736-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072736-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072736-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072736-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072736-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072736-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072736-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072736-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072736-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31adef49-84cb-4c51-b122-69e924e10ea3Product name420240827
df40773e-fe5a-474c-8d32-d19c7094e396Product name220240813
cd1aa5b9-18a7-4dc4-8a13-b5c677c859a2Product name120231116
38866763-6a8e-4096-95c3-082a000c243dProduct name120230809
7ce39568-aceb-b33a-23ed-c4964cdcf486Product name220210211
6c712ad1-eecf-448f-84d9-5c0c307a7112Product name120161130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6703-10EA - Each0904-67031be7908d-ec0f-4fea-97b9-63eaf3cc600612019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6703LEUCOVORIN CALCIUM TABLET [MAJOR PHARMACEUTICALS]5Legacy NDC20250209_8c1196d2-f4e3-4934-88ea-e855eed832ce.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leucovorin CalciumLEUCOVORIN CALCIUMHikma Pharmaceuticals USA Inc.33663425-4731-4977-9127-9e59b6b914972026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072736
application number: ANDA072736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6703-100090467031020 BLISTER PACK in 1 CARTON (0904-6703-10) > 1 TABLET in 1 BLISTER PACK20 blister pack1993-02-220000-00-00NoNoCurrent