Levoleucovorin

Product NDC
72266-121
Requested package NDC
72266-121-01
11-digit product format
722660121
Labeler code
72266
Product ID
72266-121_ebf1c3d5-e699-68bb-e053-2a95a90a9b5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levoleucovorin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fosun Pharma USA Inc.
Application
ANDA210892
Marketing category
ANDA
Marketing start
2019-06-25
Marketing end
0000-00-00
Substance
LEVOLEUCOVORIN CALCIUM
Active strength
10 mg/mL
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72266-12172266-121-01DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A210892-001LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-14
A210892-002LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210892-001AP
A210892-002AP

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAPRS2018-09-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210892-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A210892-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2018-09-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210892-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210892-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210892-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210892-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210892-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210892-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210892-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210892-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210892-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210892-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210892-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210892-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210892-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210892-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210892-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210892-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210892-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210892-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210892-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210892-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210892-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210892-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210892-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210892-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210892-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210892-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210892-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210892-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210892-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210892-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210892-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210892-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210892-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210892-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210892-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210892-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210892-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210892-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210892-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210892-002AP1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-121-01ML - Milliliter72266-121ef64fe5f-8eb8-4b18-97ae-8b8b166b048412019-08-06

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
levoleucovorinLEVOLEUCOVORINGland Pharma Limiteddbb3613c-78a9-4a96-a766-17e7a9e8809b2020-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210892
application number: ANDA210892
LEVOLEUCOVORINLEVOLEUCOVORINDr.Reddy's Laboratories Incc003aaed-89c3-d6a6-0d34-18851b7e12552017-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210892
application number: ANDA210892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-121-01722660121011 VIAL in 1 CARTON (72266-121-01) > 25 mL in 1 VIAL1 vial2019-06-250000-00-00NoNoCurrent