Leucovorin

Product NDC: 68001-285
11-digit product format: 680010285
Labeler code: 68001
Product ID: 68001-285_f73c5c51-46ca-4669-8b7e-f76d964e6696
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Leucovorin Calcium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: BluePoint Laboratories
Application: ANDA200753
Marketing category: ANDA
Marketing start: 2016-07-01
Marketing end: 0000-00-00
Substance: LEUCOVORIN CALCIUM
Active strength: 10 mg/mL
Pharmacologic classes: Folate Analog [EPC],Folic Acid [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68001-285		D	Discontinued by firm	2026-08-11
excluded package	package	68001-285	68001-285-36	D	Discontinued by firm	2026-08-11
excluded package	package	68001-285	68001-285-37	D	Discontinued by firm	2026-08-11
excluded package	package	68001-285	68001-285-40	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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-285-36	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-285-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-285-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68001-285-36	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68001-285-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68001-285-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68001-285-36	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68001-285-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68001-285-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68001-285-36	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68001-285-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68001-285-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68001-285-36	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68001-285-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68001-285-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68001-285-36	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68001-285-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68001-285-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68001-285-36	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68001-285-37	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68001-285-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68001-285-36	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68001-285-37	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68001-285-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68001-285-36	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68001-285-37	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68001-285-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68001-285-36	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68001-285-37	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68001-285-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68001-285-36	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68001-285-37	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68001-285-40	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68001-285-36	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68001-285-37	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68001-285-40	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200753-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200753-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200753-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-09-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200753-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200753-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200753-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200753-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200753-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200753-001	AP	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-285-22	EA - Each	68001-285	3caa7aeb-bb95-46ad-85f9-8b690193f6a1	1	2016-12-07
68001-285-28	EA - Each	68001-285	92ca728b-1f5c-4834-8699-3da9c2c347ef	1	2016-12-07
68001-285-29	EA - Each	68001-285	31b6bbc0-0091-4367-b44a-33a2f6ce1f45	1	2016-12-07
68001-285-36	EA - Each	68001-285	6bb5ed52-42b1-49d8-864d-d5ecfd5c2510	1	2016-12-07
68001-285-37	EA - Each	68001-285	02dcfe89-176d-4431-a286-dcceaaaed46c	1	2016-12-07
68001-285-40	EA - Each	68001-285	e663d3b7-fea5-43a5-8777-187b9cdea56c	1	2016-12-07

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

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
68001-285-36	68001028536	1 VIAL in 1 CARTON (68001-285-36) > 10 mL in 1 VIAL (68001-285-28)	1 vial	2016-07-01	0000-00-00	No	No	Current
68001-285-37	68001028537	1 VIAL in 1 CARTON (68001-285-37) > 20 mL in 1 VIAL (68001-285-29)	1 vial	2016-07-01	0000-00-00	No	No	Current
68001-285-40	68001028540	10 VIAL in 1 CARTON (68001-285-40) > 5 mL in 1 VIAL (68001-285-22)	10 vial	2016-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leucovorin Calcium for Injection (For Intravenous or Intramuscular Use)	BluePoint Laboratories \| Sagent Pharmaceuticals \| Cadila Healthcare Limited	2016-10-25	HUMAN PRESCRIPTION DRUG LABEL	2