Leucovorin Calcium

Product NDC
60687-227
11-digit product format
606870227
Labeler code
60687
Product ID
60687-227_2b230d33-950d-ca83-e063-6294a90ab298
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA071199
Marketing category
ANDA
Marketing start
2017-02-17
Substance
LEUCOVORIN CALCIUM
Active strength
25 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071199-001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071199-001AB

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 UTC2026-02A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-243f01610625f2…
2019-09-15 20:21 UTC2019-09A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071199-001LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB1987-09-24cb3db0bc1861…

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 UTC2026-02A071199-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071199-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071199-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071199-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071199-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071199-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071199-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071199-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071199-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071199-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071199-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071199-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071199-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071199-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071199-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071199-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071199-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071199-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071199-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071199-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071199-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071199-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071199-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071199-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071199-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071199-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071199-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071199-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071199-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071199-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071199-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071199-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071199-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071199-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071199-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071199-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071199-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071199-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071199-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071199-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Leucovorin Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RPR1R4C0P4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197862Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7004cbd-9827-466e-9683-adce4f13c6a6Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-227-11Leucovorin Calcium1 in 1 BLISTER PACKTABLET18
60687-227-94Leucovorin Calcium20 in 1 BOX, UNIT-DOSETABLET208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-227-11EA - Each60687-2275f5bd711-144e-4b03-8549-12255801aa4d12017-03-06
60687-227-94EA - Each60687-22715716566-3b07-4579-93ee-7fa6e790956c12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-227LEUCOVORIN CALCIUM TABLET [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20250109_f7004cbd-9827-466e-9683-adce4f13c6a6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leucovorin CalciumLEUCOVORIN CALCIUMAmerican Health Packagingf7004cbd-9827-466e-9683-adce4f13c6a62026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071199
application number: ANDA071199
ndc (product): 60687-227
Leucovorin CalciumLEUCOVORIN CALCIUMTeva Pharmaceuticals USA, Inc.94669fc8-3c1c-4228-be27-09a1cd468c362026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071199
application number: ANDA071199

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197862leucovorin calcium 25 MG Oral TabletPSNf7004cbd-9827-466e-9683-adce4f13c6a68
197862leucovorin 25 MG Oral TabletSCDf7004cbd-9827-466e-9683-adce4f13c6a68
197862leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral TabletSYf7004cbd-9827-466e-9683-adce4f13c6a68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-227-11606870227111 in 1 BLISTER PACKHistorical
60687-227-946068702279420 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-227-94) / 1 TABLET in 1 BLISTER PACK (60687-227-11) 20 blister pack2017-02-170000-00-00NoNoCurrent