Mycophenolic Acid

Product NDC: 51079-509
11-digit product format: 510790509
Labeler code: 51079
Product ID: 51079-509_f0e6145a-649e-387c-e053-2a95a90ab099
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenilic acid
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA091248
Marketing category: ANDA
Marketing start: 2014-01-20
Marketing end: 2023-09-30
Substance: MYCOPHENOLIC ACID
Active strength: 360 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51079-509		D	Discontinued by firm		2026-09-14
excluded package	package	51079-509	51079-509-20	D	Discontinued by firm		2026-09-14

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 · 24 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	51079-509-20	`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	51079-509-20	`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	51079-509-20	`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	51079-509-20	`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	51079-509-20	`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	51079-509-20	`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	51079-509-20	`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	51079-509-20	`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	51079-509-20	`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	51079-509-20	`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	51079-509-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51079-509-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091248-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL			2014-01-08
A091248-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL			2014-01-08

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A091248-001	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL		2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091248-002	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL		2014-01-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091248-001	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL		2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091248-002	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL		2014-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091248-001	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL		2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091248-002	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL		2014-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091248-001	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091248-002	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091248-001	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091248-002	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091248-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091248-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091248-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091248-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091248-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091248-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091248-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091248-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091248-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091248-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091248-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091248-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091248-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091248-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091248-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091248-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091248-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091248-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091248-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091248-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091248-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091248-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091248-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091248-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091248-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091248-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091248-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091248-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091248-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091248-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091248-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091248-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091248-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091248-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091248-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091248-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091248-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091248-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091248-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091248-002	AB	1	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-509-01	EA - Each	51079-509	fd8fbf85-a0af-4ab2-900a-2c5aa2e1e606	1	2014-04-03
51079-509-20	EA - Each	51079-509	3cf4beaa-8e55-4c62-8d23-3d543da798a3	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MYCOPHENOLIC ACID	ACTIVE INGREDIENT	HU9DX48N0T	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
MYCOPHENOLIC ACID	ACTIVE MOIETY	HU9DX48N0T	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)	INACTIVE INGREDIENT	36BGF0E889	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	MYCOPHENOLIC ACID (MYCOPHENILIC ACID) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1

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
Mycophenolic Acid	MYCOPHENILIC ACID	Archis Pharma LLC	30cb1078-929b-4c0f-be1d-49ef352dfab9	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091248 application number: ANDA091248

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HU9DX48N0T	MYCOPHENOLIC ACID	24280-93-1	MYCOPHENOLIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-509-20	51079050920	100 BLISTER PACK in 1 CARTON (51079-509-20) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (51079-509-01)	100 blister pack	2014-01-20	0000-00-00	No	No	Current