Levoleucovorin

Product NDC
71288-105
11-digit product format
712880105
Labeler code
71288
Product ID
71288-105_17100790-fb82-43cd-80eb-b3e73d918bbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levoleucovorin calcium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211002
Marketing category
ANDA
Marketing start
2019-08-16
Substance
LEVOLEUCOVORIN CALCIUM
Active strength
10 mg/mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211002-001LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-16
A211002-002LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211002-001AP

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.

Product history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2019-08-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2019-08-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211002-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A211002-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2019-08-16782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211002-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211002-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211002-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211002-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211002-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211002-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211002-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211002-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211002-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211002-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211002-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211002-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211002-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211002-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211002-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211002-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211002-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211002-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211002-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211002-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211002-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211002-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211002-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211002-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211002-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211002-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211002-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211002-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A211002-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A211002-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211002-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A211002-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211002-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A211002-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211002-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A211002-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A211002-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A211002-002AP1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211002-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211002-001AP11c564ffb4f44…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOLEUCOVORIN CALCIUM10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
778XL6VBS8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1720765Internal RxNorm lookup
1720773Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
059a3306-6207-497f-a947-33198f18761fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
d5f7850a-bc65-4866-8340-2b197ae4d8caProduct name920200206
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2642c4da-5f9c-4531-8406-dc7d1c3a9032Product name120190201
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
71288-105-18Levoleucovorin17.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION17.59
71288-105-18Levoleucovorin1 in 1 CARTONINJECTION, SOLUTION19
71288-105-25Levoleucovorin1 in 1 CARTONINJECTION, SOLUTION19
71288-105-25Levoleucovorin25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-105LEVOLEUCOVORIN (LEVOLEUCOVORIN CALCIUM) INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 4 package rows20240110_059a3306-6207-497f-a947-33198f18761f.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
LevoleucovorinLEVOLEUCOVORIN CALCIUMMeitheal Pharmaceuticals Inc.059a3306-6207-497f-a947-33198f18761f2023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211002
application number: ANDA211002
ndc (product): 71288-105

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1720765LEVOleucovorin 175 MG in 17.5 mL InjectionPSN059a3306-6207-497f-a947-33198f18761f9
1720773LEVOleucovorin 250 MG in 25 ML InjectionPSN059a3306-6207-497f-a947-33198f18761f9
172076517.5 ML levoleucovorin 10 MG/ML InjectionSCD059a3306-6207-497f-a947-33198f18761f9
172077325 ML levoleucovorin 10 MG/ML InjectionSCD059a3306-6207-497f-a947-33198f18761f9
1720765levoleucovorin (as levoleucovorin calcium) 175 MG per 17.5 mL InjectionSY059a3306-6207-497f-a947-33198f18761f9
1720773levoleucovorin (as levoleucovorin calcium) 250 MG per 25 ML InjectionSY059a3306-6207-497f-a947-33198f18761f9
1720765levoleucovorin 175 MG per 17.5 mL InjectionSY059a3306-6207-497f-a947-33198f18761f9
1720773levoleucovorin 250 MG per 25 ML InjectionSY059a3306-6207-497f-a947-33198f18761f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-105-18712880105181 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-18) / 17.5 mL in 1 VIAL, SINGLE-DOSE2019-08-160000-00-00NoNoCurrent
71288-105-25712880105251 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25) / 25 mL in 1 VIAL, SINGLE-DOSE2019-08-160000-00-00NoNoCurrent