Mycophenolate Mofetil

Product NDC: 55154-5382
Requested package NDC: 55154-5382-0
11-digit product format: 551545382
Labeler code: 55154
Product ID: 55154-5382_700941b9-de3e-49c7-bca2-f85663cdf223
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolate mofetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA065521
Marketing category: ANDA
Marketing start: 2011-10-25
Marketing end: 2030-01-31
Substance: MYCOPHENOLATE MOFETIL
Active strength: 500 mg/1
Pharmacologic classes: Antimetabolite Immunosuppressant [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	55154-5382	55154-5382-0	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 · 11 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…`

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
A065521-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL			2009-05-04

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	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065521-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`e64feba35796…`

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	A065521-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065521-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065521-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065521-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065521-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065521-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065521-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065521-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065521-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065521-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065521-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065521-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065521-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065521-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065521-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065521-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065521-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065521-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065521-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065521-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065521-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065521-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065521-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065521-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065521-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065521-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065521-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065521-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065521-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065521-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065521-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065521-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065521-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065521-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065521-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065521-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065521-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065521-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065521-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065521-001	AB	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MYCOPHENOLATE MOFETIL	ACTIVE INGREDIENT	9242ECW6R0	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
MYCOPHENOLIC ACID	ACTIVE MOIETY	HU9DX48N0T	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]	6

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	Aphena Pharma Solutions - Tennessee, LLC	721564bc-7c0b-4418-ab49-0af362e74eb7	2024-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065521 application number: ANDA065521

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
55154-5382-0	55154538200	10 BLISTER PACK in 1 BAG (55154-5382-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2011-10-25	2030-01-31	No	No	Current