LEUCOVORIN CALCIUM

Product NDC
67457-528
11-digit product format
674570528
Labeler code
67457
Product ID
67457-528_2890b03c-dbef-4db8-8b07-c042d7765677
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEUCOVORIN CALCIUM
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA203800
Marketing category
ANDA
Marketing start
2019-07-23
Substance
LEUCOVORIN CALCIUM
Active strength
100 mg/10mL
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUMEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19
A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUMEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19
A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203800-001AP
A203800-002AP
A203800-003AP

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203800-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203800-003LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203800-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2017-05-198072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203800-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203800-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203800-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203800-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203800-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203800-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203800-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203800-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203800-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203800-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203800-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203800-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203800-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203800-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203800-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203800-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203800-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203800-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203800-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203800-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203800-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203800-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203800-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203800-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203800-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203800-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203800-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203800-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203800-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203800-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203800-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203800-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203800-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203800-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203800-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203800-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203800-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203800-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203800-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203800-001AP18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM100 mg/10mL

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
237788Internal RxNorm lookup
1803932Internal RxNorm lookup
1803937Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cb701ca-2478-4268-9d69-80293965d59dAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
38866763-6a8e-4096-95c3-082a000c243dProduct name120230809
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
7ce39568-aceb-b33a-23ed-c4964cdcf486Product name220210211
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
6c712ad1-eecf-448f-84d9-5c0c307a7112Product name120161130
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-528-10LEUCOVORIN CALCIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
67457-528-10LEUCOVORIN CALCIUM10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-528-10EA - Each67457-528fe067acd-49cf-4ec6-8cf0-d375f6fcd38712019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-528LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [MYLAN INSTITUTIONAL LLC]4Current NDC, Legacy NDC, 2 package rows20230105_1cb701ca-2478-4268-9d69-80293965d59d.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 CALCIUMMylan Institutional LLC1cb701ca-2478-4268-9d69-80293965d59d2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203800
application number: ANDA203800
ndc (product): 67457-528

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1803932leucovorin 100 MG InjectionPSN1cb701ca-2478-4268-9d69-80293965d59d4
1803937leucovorin 200 MG InjectionPSN1cb701ca-2478-4268-9d69-80293965d59d4
237788leucovorin 350 MG InjectionPSN1cb701ca-2478-4268-9d69-80293965d59d4
1803932leucovorin 100 MG InjectionSCD1cb701ca-2478-4268-9d69-80293965d59d4
1803937leucovorin 200 MG InjectionSCD1cb701ca-2478-4268-9d69-80293965d59d4
237788leucovorin 350 MG InjectionSCD1cb701ca-2478-4268-9d69-80293965d59d4
1803932leucovorin (as leucovorin calcium) 100 MG InjectionSY1cb701ca-2478-4268-9d69-80293965d59d4
1803937leucovorin (as leucovorin calcium) 200 MG InjectionSY1cb701ca-2478-4268-9d69-80293965d59d4
237788leucovorin (as leucovorin calcium) 350 MG InjectionSY1cb701ca-2478-4268-9d69-80293965d59d4
237788leucovorin 350 MG per 17.5 ML Lyophilized Powder for InjectionSY1cb701ca-2478-4268-9d69-80293965d59d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-528-10674570528101 VIAL, SINGLE-DOSE in 1 CARTON (67457-528-10) / 10 mL in 1 VIAL, SINGLE-DOSE2019-07-230000-00-00NoNoCurrent