LEUCOVORIN CALCIUM

Product NDC
71205-908
11-digit product format
712050908
Labeler code
71205
Product ID
71205-908_349c3831-62bc-4f66-9c19-5185520af6c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEUCOVORIN CALCIUM
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA213929
Marketing category
ANDA
Marketing start
2020-11-16
Substance
LEUCOVORIN CALCIUM
Active strength
5 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213929-001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-22
A213929-002LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-22
A213929-003LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-22
A213929-004LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A213929-001AB
A213929-002AB
A213929-003AB
A213929-004AB

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 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213929-001LEUCOVORIN CALCIUMEQ 5MG BASETABLET / ORALAB2020-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213929-002LEUCOVORIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213929-003LEUCOVORIN CALCIUMEQ 15MG BASETABLET / ORALAB2020-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213929-004LEUCOVORIN CALCIUMEQ 25MG BASETABLET / ORALAB2020-10-22d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213929-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213929-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213929-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213929-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213929-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213929-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213929-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213929-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213929-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213929-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213929-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213929-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213929-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213929-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213929-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213929-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213929-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213929-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213929-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213929-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213929-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213929-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213929-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213929-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213929-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213929-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213929-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213929-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213929-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213929-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213929-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213929-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213929-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213929-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213929-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213929-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213929-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213929-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213929-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213929-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
LEUCOVORIN CALCIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM5 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
197863Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46d12bd0-ec7d-4e2c-aeed-b8aa88e6dc5cAvailable 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
71205-908-00LEUCOVORIN CALCIUM100 in 1 BOTTLETABLET1002
71205-908-11LEUCOVORIN CALCIUM1000 in 1 BOTTLETABLET10002
71205-908-30LEUCOVORIN CALCIUM30 in 1 BOTTLETABLET302
71205-908-55LEUCOVORIN CALCIUM500 in 1 BOTTLETABLET5002
71205-908-60LEUCOVORIN CALCIUM60 in 1 BOTTLETABLET602
71205-908-90LEUCOVORIN CALCIUM90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-908-00EA - Each71205-908ba8cff2b-19c8-4b7c-a6a7-71d2cddce86512021-08-05
71205-908-11EA - Each71205-908b7372435-5816-431c-9056-30de9c697d6c12021-08-05
71205-908-55EA - Each71205-908c5daf9d1-091c-4dc7-8b76-6073ab44a61912021-08-05
71205-908-60EA - Each71205-90870298362-2702-4739-b90f-5b394fc8cacb12021-08-05
71205-908-90EA - Each71205-908774f1849-e2ac-47d3-9774-d4af49dd342c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-908LEUCOVORIN CALCIUM TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20220402_46d12bd0-ec7d-4e2c-aeed-b8aa88e6dc5c.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 CALCIUMLeading Pharma, LLCc8102043-79f2-421a-b849-94bac19007a62026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213929
application number: ANDA213929
LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMProficient Rx LP46d12bd0-ec7d-4e2c-aeed-b8aa88e6dc5c2022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213929
application number: ANDA213929
ndc (product): 71205-908

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197863leucovorin calcium 5 MG Oral TabletPSN46d12bd0-ec7d-4e2c-aeed-b8aa88e6dc5c2
197863leucovorin 5 MG Oral TabletSCD46d12bd0-ec7d-4e2c-aeed-b8aa88e6dc5c2
197863leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral TabletSY46d12bd0-ec7d-4e2c-aeed-b8aa88e6dc5c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-908-0071205090800100 TABLET in 1 BOTTLE (71205-908-00) 100 tablet2021-07-160000-00-00NoNoCurrent
71205-908-11712050908111000 TABLET in 1 BOTTLE (71205-908-11) 1000 tablet2021-07-160000-00-00NoNoCurrent
71205-908-307120509083030 TABLET in 1 BOTTLE (71205-908-30) 30 tablet2021-07-160000-00-00NoNoCurrent
71205-908-5571205090855500 TABLET in 1 BOTTLE (71205-908-55) 500 tablet2021-07-160000-00-00NoNoCurrent
71205-908-607120509086060 TABLET in 1 BOTTLE (71205-908-60) 60 tablet2021-07-160000-00-00NoNoCurrent
71205-908-907120509089090 TABLET in 1 BOTTLE (71205-908-90) 90 tablet2021-07-160000-00-00NoNoCurrent