mycophenolate mofetil

Product NDC: 70518-3068
11-digit product format: 705183068
Labeler code: 70518
Product ID: 70518-3068_bf775fb5-7346-cef2-e053-2995a90ad9e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolate mofetil
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA200197
Marketing category: ANDA
Marketing start: 2021-04-07
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-3068		D	Discontinued by firm		2026-08-17
excluded package	package	70518-3068	70518-3068-0	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 · 4 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	70518-3068-0	`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	70518-3068-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A200197-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB		2013-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200197-001	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	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200197-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2013-06-13	`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	A200197-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200197-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200197-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200197-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200197-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200197-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200197-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200197-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200197-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200197-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200197-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200197-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200197-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200197-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200197-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200197-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200197-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200197-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200197-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200197-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200197-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200197-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200197-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200197-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200197-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200197-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200197-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200197-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200197-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200197-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200197-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200197-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200197-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200197-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200197-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200197-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200197-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200197-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200197-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200197-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3068-0	2023-03-15	C162847	48780-1	f386c64a-1e25-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES MYCOPHENOLATE MOFETIL tablets, for oral use MYCOPHENOLATE MOFETIL capsules, for oral use Initial U.S. Approval: 1995
70518-3068-0	2023-01-30	C162847	48780-1	f386c64a-1e25-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES MYCOPHENOLATE MOFETIL tablets, for oral use MYCOPHENOLATE MOFETIL capsules, 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
70518-3068	MYCOPHENOLATE MOFETIL CAPSULE [REMEDYREPACK INC.]	4	Legacy NDC	20241116_1b44c6c4-dfb5-47ed-8201-d7173b3b9887.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Major Pharmaceuticals	6abc5727-ee8e-43ad-ab39-0eef2feb257a	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200197 application number: ANDA200197
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Ascend Laboratories, LLC	9f84ea84-2d8b-4d91-a33f-7dfb5df937dc	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200197 application number: ANDA200197
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	AvPAK	fbbe6521-0e21-5372-e053-6394a90ae5e4	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200197 application number: ANDA200197
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	American Health Packaging	75a76397-bb62-4014-8488-949a711b25f0	2025-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200197 application number: ANDA200197

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
70518-3068-0	70518306800	100 POUCH in 1 BOX (70518-3068-0) > 1 CAPSULE in 1 POUCH (70518-3068-1)	100 pouch	2021-04-07	0000-00-00	No	No	Current