Mycophenolate Mofetil

Product NDC: 0480-3571
11-digit product format: 004803571
Labeler code: 0480
Product ID: 0480-3571_fe465904-2fbd-47a9-96e4-99fd7bfc5c0d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mycophenolate Mofetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA065451
Marketing category: ANDA
Marketing start: 2022-09-09
Marketing end: 0000-00-00
Substance: MYCOPHENOLATE MOFETIL
Active strength: 500 mg/1
Pharmacologic classes: Antimetabolite Immunosuppressant [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0480-3571		D	Discontinued by firm	2026-08-17
excluded package	package	0480-3571	0480-3571-01	D	Discontinued by firm	2026-08-17
excluded package	package	0480-3571	0480-3571-05	D	Discontinued by firm	2026-08-17

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 · 33 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	0480-3571-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0480-3571-01	`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	0480-3571-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0480-3571-01	`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	0480-3571-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0480-3571-01	`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	0480-3571-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0480-3571-01	`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	0480-3571-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0480-3571-01	`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	0480-3571-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0480-3571-01	`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	0480-3571-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0480-3571-01	`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	0480-3571-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0480-3571-01	`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	0480-3571-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0480-3571-01	`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	0480-3571-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0480-3571-01	`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	0480-3571-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0480-3571-01	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065451-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB		2008-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065451-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065451-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2008-10-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065451-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065451-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065451-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065451-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065451-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065451-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065451-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065451-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065451-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065451-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065451-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065451-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065451-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065451-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065451-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065451-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065451-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065451-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065451-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065451-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065451-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065451-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065451-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065451-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065451-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065451-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065451-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065451-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065451-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065451-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065451-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065451-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065451-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065451-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065451-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065451-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065451-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065451-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065451-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065451-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0480-3571-01	2023-11-02	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS.MYCOPHENOLATE mofetil tablets, for oral use Initial U.S. Approval: 1995
0480-3571-05	2023-11-02	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS.MYCOPHENOLATE mofetil tablets, for oral use Initial U.S. Approval: 1995
0480-3571-01	2023-07-28	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS.MYCOPHENOLATE mofetil tablets, for oral use Initial U.S. Approval: 1995
0480-3571-05	2023-07-28	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS.MYCOPHENOLATE mofetil tablets, for oral use Initial U.S. Approval: 1995

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0480-3571-01	EA - Each	0480-3571	ea7d33fd-9400-4fab-b16a-04d84b56678e	1	2022-10-06
0480-3571-05	EA - Each	0480-3571	c9e6be4e-c7c0-4b4c-ba4b-65e9e00b43b7	1	2022-10-06

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Sandoz Inc	99b2eb58-8d14-48fc-bbe1-aacb711a783e	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065451 application number: ANDA065451

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9242ECW6R0	MYCOPHENOLATE MOFETIL	128794-94-5	MYCOPHENOLATE MOFETIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0480-3571-01	00480357101	100 TABLET, FILM COATED in 1 BOTTLE (0480-3571-01)	2022-09-09	0000-00-00	No	No	Current
0480-3571-05	00480357105	500 TABLET, FILM COATED in 1 BOTTLE (0480-3571-05)	2022-09-09	0000-00-00	No	No	Current