Leucovorin Calcium

Product NDC: 51079-581
Requested package NDC: 51079-581-06
11-digit product format: 510790581
Labeler code: 51079
Product ID: 51079-581_d44fba64-c6ed-47dd-e053-2995a90a8d08
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Leucovorin Calcium
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA071198
Marketing category: ANDA
Marketing start: 1996-02-26
Marketing end: 0000-00-00
Substance: LEUCOVORIN CALCIUM
Active strength: 5 mg/1
Pharmacologic classes: Folate Analog [EPC],Folic Acid [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51079-581	51079-581-06	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071198-001	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		1987-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071198-001	AB

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 · 43 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	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071198-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	1987-09-24	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A071198-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071198-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071198-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071198-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071198-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071198-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071198-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071198-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071198-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071198-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071198-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071198-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071198-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071198-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071198-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071198-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071198-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071198-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071198-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071198-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071198-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071198-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071198-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071198-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071198-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071198-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071198-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071198-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071198-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071198-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071198-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071198-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071198-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071198-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071198-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071198-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071198-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071198-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071198-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071198-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-581-01	EA - Each	51079-581	719beb15-ddbf-4923-9cf1-861677047a38	1	2012-07-24
51079-581-06	EA - Each	51079-581	2d9bd70e-f494-4b53-afdf-e3772c77fcb3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEUCOVORIN CALCIUM	ACTIVE INGREDIENT	RPR1R4C0P4	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
LEUCOVORIN	ACTIVE MOIETY	Q573I9DVLP	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3

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	Teva Pharmaceuticals USA, Inc.	94669fc8-3c1c-4228-be27-09a1cd468c36	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071198 application number: ANDA071198

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-581-06	51079058106	50 BLISTER PACK in 1 CARTON (51079-581-06) > 1 TABLET in 1 BLISTER PACK (51079-581-01)	50 blister pack	1996-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leucovorin Calcium Tablets USP	Mylan institutional Inc.	2022-12-28	HUMAN PRESCRIPTION DRUG LABEL	9