FDA.reportPublic FDA data

Leucovorin Calcium

Product NDC
68462-767
11-digit product format
684620767
Labeler code
68462
Product ID
68462-767_79d023ab-7d77-48c1-8f47-ea322fd58c2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA218200
Marketing category
ANDA
Marketing start
2025-11-12
Substance
LEUCOVORIN CALCIUM
Active strength
350 mg/17.5mL
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
A218200-001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2025-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218200-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218200-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2025-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218200-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2025-11-1231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218200-001LEUCOVORIN CALCIUMEQ 350MG BASE/VIALINJECTABLE / INJECTIONAP2025-11-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218200-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218200-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218200-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Leucovorin Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM350 mg/17.5mL

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
237788Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
79d023ab-7d77-48c1-8f47-ea322fd58c2bAvailable 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
68462-767-35Leucovorin Calcium17.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,17.51
68462-767-35Leucovorin Calcium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-767-35EA - Each68462-767654effe6-0bfd-4c67-9337-6f10c4f6848c12026-01-08

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 CALCIUMGLENMARK PHARMACEUTICALS INC., USA79d023ab-7d77-48c1-8f47-ea322fd58c2b2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218200
application number: ANDA218200
ndc (product): 68462-767
Leucovorin CalciumLEUCOVORIN CALCIUMGland Pharma Limited968b192b-72f3-41b0-a1f5-bab8a96d34192025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218200
application number: ANDA218200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237788leucovorin 350 MG InjectionPSN79d023ab-7d77-48c1-8f47-ea322fd58c2b1
237788leucovorin 350 MG InjectionSCD79d023ab-7d77-48c1-8f47-ea322fd58c2b1
237788leucovorin (as leucovorin calcium) 350 MG InjectionSY79d023ab-7d77-48c1-8f47-ea322fd58c2b1
237788leucovorin 350 MG per 17.5 ML Lyophilized Powder for InjectionSY79d023ab-7d77-48c1-8f47-ea322fd58c2b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-767-35684620767351 VIAL in 1 CARTON (68462-767-35) / 17.5 mL in 1 VIAL1 vial2025-11-12NoNoCurrent