Leucovorin Calcium

Product NDC: 25021-814
Requested package NDC: 25021-814-67
11-digit product format: 250210814
Labeler code: 25021
Product ID: 25021-814_a0aa8531-741f-4b28-8ba6-c2159e9a1599
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leucovorin calcium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA200753
Marketing category: ANDA
Marketing start: 2012-09-15
Substance: LEUCOVORIN CALCIUM
Active strength: 100 mg/10mL
Pharmacologic classes: Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	25021-814	25021-814-67	D	Discontinued by firm		2026-10-05

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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06
A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06
A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200753-001	AP
A200753-002	AP
A200753-003	AP

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 · 129 observed 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
2026-09-14 22:38:34	2026-08	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200753-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200753-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200753-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200753-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200753-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200753-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200753-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200753-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200753-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200753-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200753-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200753-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200753-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200753-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200753-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200753-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200753-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200753-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200753-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200753-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200753-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200753-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200753-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200753-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200753-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200753-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200753-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200753-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200753-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200753-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200753-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200753-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200753-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200753-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200753-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200753-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200753-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200753-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200753-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200753-001	AP	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Leucovorin Calcium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEUCOVORIN CALCIUM	100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RPR1R4C0P4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
237788	Internal RxNorm lookup
1803930	Internal RxNorm lookup
1803932	Internal RxNorm lookup
1803937	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
9d0e5356-ff39-4a8e-944c-e808a21ef4b2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
31adef49-84cb-4c51-b122-69e924e10ea3	Product name	4	20240827
df40773e-fe5a-474c-8d32-d19c7094e396	Product name	2	20240813
cd1aa5b9-18a7-4dc4-8a13-b5c677c859a2	Product name	1	20231116
38866763-6a8e-4096-95c3-082a000c243d	Product name	1	20230809
7ce39568-aceb-b33a-23ed-c4964cdcf486	Product name	2	20210211
6c712ad1-eecf-448f-84d9-5c0c307a7112	Product name	1	20161130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25021-814-30	Leucovorin Calcium	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10		9
25021-814-30	Leucovorin Calcium	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-814-30	EA - Each	25021-814	93a8106a-a98f-42ab-8120-356b6400ca96	1	2013-02-13
25021-814-67	EA - Each	25021-814	02b2a3b7-0b47-430f-beaf-8e267ebf98ae	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
leucovorin calcium	ACTIVE INGREDIENT	RPR1R4C0P4	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	5
leucovorin	ACTIVE MOIETY	Q573I9DVLP	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	5
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	5
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	5
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	5
leucovorin calcium	ACTIVE INGREDIENT	RPR1R4C0P4	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	3
leucovorin	ACTIVE MOIETY	Q573I9DVLP	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	3
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	3
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	3
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-814	LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 2 package rows	20221201_9d0e5356-ff39-4a8e-944c-e808a21ef4b2.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
Leucovorin Calcium	LEUCOVORIN CALCIUM	Sagent Pharmaceuticals	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200753 application number: ANDA200753 ndc (product): 25021-814

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RPR1R4C0P4	LEUCOVORIN CALCIUM	1492-18-8	LEUCOVORIN CALCIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1803932	leucovorin 100 MG Injection	PSN	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
1803937	leucovorin 200 MG Injection	PSN	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
237788	leucovorin 350 MG Injection	PSN	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
1803930	leucovorin 50 MG Injection	PSN	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
1803932	leucovorin 100 MG Injection	SCD	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
1803937	leucovorin 200 MG Injection	SCD	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
237788	leucovorin 350 MG Injection	SCD	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
1803930	leucovorin 50 MG Injection	SCD	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
1803932	leucovorin (as leucovorin calcium) 100 MG Injection	SY	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
1803937	leucovorin (as leucovorin calcium) 200 MG Injection	SY	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
237788	leucovorin (as leucovorin calcium) 350 MG Injection	SY	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
1803930	leucovorin (as leucovorin calcium) 50 MG Injection	SY	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9
237788	leucovorin 350 MG per 17.5 ML Lyophilized Powder for Injection	SY	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-814-67	25021081467	1 VIAL in 1 CARTON (25021-814-67) > 10 mL in 1 VIAL	1 vial	2013-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leucovorin Calcium for Injection, USP (For Intravenous or Intramuscular Use)	Sagent Pharmaceuticals	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	10
Leucovorin Calcium for Injection (For Intravenous or Intramuscular Use)	Sagent Pharmaceuticals	2021-06-29	HUMAN PRESCRIPTION DRUG LABEL	5