Mycophenolate Mofetil

Product NDC: 70748-262
Requested package NDC: 70748-262-01
11-digit product format: 707480262
Labeler code: 70748
Product ID: 70748-262_ecc0d5bc-feca-4534-80c3-331e0fe63b28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolate mofetil
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA212087
Marketing category: ANDA
Marketing start: 2020-12-21
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70748-262	70748-262-01	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 · 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 1.

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
A212087-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB		2020-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212087-001	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.

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	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212087-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212087-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212087-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212087-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212087-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212087-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212087-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212087-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212087-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212087-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212087-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212087-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212087-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212087-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212087-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212087-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212087-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212087-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212087-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212087-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212087-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212087-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212087-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212087-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212087-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212087-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212087-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212087-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212087-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212087-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212087-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212087-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212087-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212087-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212087-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212087-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212087-001	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	Advagen Pharma Limited	a15c26d8-5a27-48ba-a669-8546803d901f	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212087 application number: ANDA212087
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	CONCORD BIOTECH LIMITED	64ac00ee-298c-49cf-a91c-78019a0d014d	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212087 application number: ANDA212087

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
70748-262-01	70748026201	100 TABLET in 1 BOTTLE (70748-262-01)	100 tablet	2020-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mycophenolate Mofetil	Lupin Pharmaceuticals, Inc. \| CONCORD BIOTECH LIMITED	2023-12-29	HUMAN PRESCRIPTION DRUG LABEL	5