Levoleucovorin

Product NDC: 71288-104
11-digit product format: 712880104
Labeler code: 71288
Product ID: 71288-104_a0d839ca-80eb-4061-a0c4-30e5d94af094
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levoleucovorin calcium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Meitheal Pharmaceuticals Inc
Application: ANDA211003
Marketing category: ANDA
Marketing start: 2019-08-22
Substance: LEVOLEUCOVORIN CALCIUM
Active strength: 50 mg/5mL
Pharmacologic classes: Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71288-104	71288-104-10	D	Discontinued by firm		2026-08-11

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211003-001	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS			2019-08-22

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211003-001	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		2019-08-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211003-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211003-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211003-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211003-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211003-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211003-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211003-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211003-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211003-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211003-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211003-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211003-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211003-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211003-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211003-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211003-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211003-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211003-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211003-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211003-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211003-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211003-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211003-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211003-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211003-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOLEUCOVORIN CALCIUM	50 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
778XL6VBS8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1720760	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b4dd0e14-d42a-4581-b1f0-7ba95b50bca6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5f7850a-bc65-4866-8340-2b197ae4d8ca	Product name	9	20200206
2642c4da-5f9c-4531-8406-dc7d1c3a9032	Product name	1	20190201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71288-104-10	Levoleucovorin	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	5		7
71288-104-10	Levoleucovorin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-104-10	EA - Each	71288-104	6fdab520-c8e6-4bed-920e-a2221568b7a4	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-104	LEVOLEUCOVORIN (LEVOLEUCOVORIN CALCIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC]	7	Current NDC, Legacy NDC, 2 package rows	20221208_b4dd0e14-d42a-4581-b1f0-7ba95b50bca6.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levoleucovorin	LEVOLEUCOVORIN CALCIUM	Meitheal Pharmaceuticals Inc	b4dd0e14-d42a-4581-b1f0-7ba95b50bca6	2022-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211003 application number: ANDA211003 ndc (product): 71288-104

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
778XL6VBS8	LEVOLEUCOVORIN CALCIUM	80433-71-2	LEVOLEUCOVORIN CALCIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1720760	LEVOleucovorin 50 MG Injection	PSN	b4dd0e14-d42a-4581-b1f0-7ba95b50bca6	7
1720760	levoleucovorin 50 MG Injection	SCD	b4dd0e14-d42a-4581-b1f0-7ba95b50bca6	7
1720760	levoleucovorin (as levoleucovorin calcium) 50 MG Injection	SY	b4dd0e14-d42a-4581-b1f0-7ba95b50bca6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-104-10	71288010410	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-104-10) > 10 mL in 1 VIAL, SINGLE-DOSE	2019-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levoleucovorin	Meitheal Pharmaceuticals Inc \| Kindos Pharmaceuticals Co., Ltd.	2022-12-06	HUMAN PRESCRIPTION DRUG LABEL	7