mycophenolate mofetil

Product NDC: 70518-2835
Requested package NDC: 70518-2835-0
11-digit product format: 705182835
Labeler code: 70518
Product ID: 70518-2835_d7703da8-7905-369e-e053-2a95a90aa485
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolate mofetil
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA090253
Marketing category: ANDA
Marketing start: 2020-08-18
Marketing end: 0000-00-00
Substance: MYCOPHENOLATE MOFETIL
Active strength: 250 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2835	70518-2835-0	D	Discontinued by firm		2026-08-17

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
A090253-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB		2009-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090253-001	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	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090253-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-05-04	`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	A090253-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090253-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090253-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090253-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090253-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090253-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090253-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090253-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090253-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090253-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090253-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090253-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090253-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090253-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090253-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090253-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090253-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090253-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090253-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090253-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090253-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090253-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090253-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090253-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090253-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090253-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090253-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090253-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090253-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090253-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090253-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090253-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090253-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090253-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090253-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090253-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090253-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090253-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090253-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090253-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2835-0	2022-02-07	C162847	48780-1	d6a99b39-e0bd-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995
70518-2835-0	2022-01-28	C162847	48780-1	d6a99b39-e0bd-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2835	MYCOPHENOLATE MOFETIL CAPSULE [REMEDYREPACK INC.]	8	Legacy NDC	20250403_90336570-e701-4f50-a19f-b5e7d6f2d293.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
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Accord Healthcare Inc.	741e079a-646b-47ec-84ac-8e12574c2aaf	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090253 application number: ANDA090253

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2835-0	70518283500	100 POUCH in 1 BOX (70518-2835-0) > 1 CAPSULE in 1 POUCH (70518-2835-1)	100 pouch	2020-08-18	0000-00-00	No	No	Current