Mycophenolic Acid

Product NDC: 60505-2965
11-digit product format: 605052965
Labeler code: 60505
Product ID: 60505-2965_fa09fa75-fabc-fac1-8b3e-772bcf55939a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mycophenolic Acid
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Apotex Corp
Application: ANDA091558
Marketing category: ANDA
Marketing start: 2012-08-21
Substance: MYCOPHENOLATE SODIUM
Active strength: 180 mg/1
Pharmacologic classes: Antimetabolite Immunosuppressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	60505-2965	60505-2965-0	D	Discontinued by firm	2026-08-11
excluded package	package	60505-2965	60505-2965-1	D	Discontinued by firm	2026-08-11
excluded package	package	60505-2965	60505-2965-3	D	Discontinued by firm	2026-08-11
excluded package	package	60505-2965	60505-2965-5	D	Discontinued by firm	2026-08-11
excluded package	package	60505-2965	60505-2965-6	D	Discontinued by firm	2026-08-11
excluded package	package	60505-2965	60505-2965-8	D	Discontinued by firm	2026-08-11
excluded package	package	60505-2965	60505-2965-9	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 2 · 84 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	60505-2965-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-2965-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-2965-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-2965-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-2965-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-2965-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-2965-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-2965-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-2965-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-2965-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-2965-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-2965-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-2965-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-2965-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-2965-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-2965-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-2965-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-2965-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-2965-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-2965-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-2965-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-2965-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-2965-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-2965-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-2965-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-2965-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-2965-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-2965-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-2965-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-2965-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-2965-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-2965-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-2965-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-2965-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-2965-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-2965-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-2965-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-2965-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-2965-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-2965-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-2965-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-2965-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-2965-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-2965-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-2965-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-2965-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-2965-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-2965-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-2965-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-2965-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-2965-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-2965-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-2965-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-2965-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-2965-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-2965-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-2965-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-2965-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-2965-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-2965-0	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091558-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2012-08-21
A091558-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2014-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091558-001	AB
A091558-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A091558-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091558-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091558-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091558-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091558-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091558-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091558-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091558-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091558-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091558-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091558-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091558-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091558-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091558-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091558-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091558-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091558-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091558-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091558-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091558-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091558-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091558-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091558-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091558-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091558-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091558-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091558-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091558-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091558-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091558-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091558-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091558-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091558-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091558-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091558-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091558-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091558-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091558-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091558-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091558-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091558-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091558-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091558-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091558-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091558-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091558-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mycophenolic Acid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MYCOPHENOLATE SODIUM	180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WX877SQI1G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485020	Internal RxNorm lookup
485023	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04b26d3d-97dc-48db-824b-10b299945382	Product name	8	20250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4b	Product name	1	20250218
267b34ba-ace4-4048-9f21-d3c7ac983fc3	Product name	9	20210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-2965-0	Mycophenolic Acid	10 in 1 CARTON	TABLET, DELAYED RELEASE	10	25
60505-2965-0	Mycophenolic Acid	10 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	10	25
60505-2965-1	Mycophenolic Acid	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100	25
60505-2965-3	Mycophenolic Acid	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	25
60505-2965-5	Mycophenolic Acid	500 in 1 BOTTLE	TABLET, DELAYED RELEASE	500	25
60505-2965-6	Mycophenolic Acid	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	25
60505-2965-7	Mycophenolic Acid	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120	25
60505-2965-8	Mycophenolic Acid	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	25
60505-2965-9	Mycophenolic Acid	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-2965-7	EA - Each	60505-2965	89b5e6c8-f17d-4520-8baa-29f7fe9c406b	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MYCOPHENOLATE SODIUM	ACTIVE INGREDIENT	WX877SQI1G	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
mycophenolic acid	ACTIVE MOIETY	HU9DX48N0T	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
METHYLCELLULOSE (400 CPS)	INACTIVE INGREDIENT	O0GN6F9B2Y	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	11
MYCOPHENOLATE SODIUM	ACTIVE INGREDIENT	WX877SQI1G	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
MYCOPHENOLATE SODIUM	ACTIVE INGREDIENT	WX877SQI1G	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
mycophenolic acid	ACTIVE MOIETY	HU9DX48N0T	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
mycophenolic acid	ACTIVE MOIETY	HU9DX48N0T	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
METHYLCELLULOSE (400 MPA.S)	INACTIVE INGREDIENT	O0GN6F9B2Y	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
METHYLCELLULOSE (400 MPA.S)	INACTIVE INGREDIENT	O0GN6F9B2Y	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-2965	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP]	24	Current NDC, Legacy NDC, 9 package rows	20250411_c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0.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
Mycophenolic Acid	MYCOPHENOLIC ACID	American Health Packaging	26b31126-4262-4a15-8a16-234c86763176	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091558 application number: ANDA091558
Mycophenolic Acid	MYCOPHENOLIC ACID	Major Pharmaceuticals	93763b39-ba21-449b-bdc5-254ba57154e4	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091558 application number: ANDA091558
Mycophenolic Acid	MYCOPHENOLIC ACID	Golden State Medical Supply, Inc.	3a0a6ef4-fb2c-47be-82d7-d2675059c45b	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091558 application number: ANDA091558
Mycophenolic Acid	MYCOPHENOLIC ACID	Apotex Corp	c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091558 application number: ANDA091558 ndc (product): 60505-2965

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WX877SQI1G	MYCOPHENOLATE SODIUM	37415-62-6	MYCOPHENOLATE SODIUM
HU9DX48N0T	MYCOPHENOLIC ACID	24280-93-1	Mycophenolic Acid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	PSN	c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	25
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	25
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	25
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	25
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	25
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	25
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	PSN	3a0a6ef4-fb2c-47be-82d7-d2675059c45b	13
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	3a0a6ef4-fb2c-47be-82d7-d2675059c45b	13
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	3a0a6ef4-fb2c-47be-82d7-d2675059c45b	13
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	3a0a6ef4-fb2c-47be-82d7-d2675059c45b	13
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	3a0a6ef4-fb2c-47be-82d7-d2675059c45b	13
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	3a0a6ef4-fb2c-47be-82d7-d2675059c45b	13
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	PSN	26b31126-4262-4a15-8a16-234c86763176	9
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	26b31126-4262-4a15-8a16-234c86763176	9
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	26b31126-4262-4a15-8a16-234c86763176	9
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	26b31126-4262-4a15-8a16-234c86763176	9
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	26b31126-4262-4a15-8a16-234c86763176	9
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	26b31126-4262-4a15-8a16-234c86763176	9
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	PSN	93763b39-ba21-449b-bdc5-254ba57154e4	5
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	93763b39-ba21-449b-bdc5-254ba57154e4	5
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	93763b39-ba21-449b-bdc5-254ba57154e4	5
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	93763b39-ba21-449b-bdc5-254ba57154e4	5
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	93763b39-ba21-449b-bdc5-254ba57154e4	5
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	93763b39-ba21-449b-bdc5-254ba57154e4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-2965-0	60505296500	10 in 1 CARTON					Historical
60505-2965-1	60505296501	100 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-1)	2012-08-21	2021-06-30	No	No	Current
60505-2965-3	60505296503	30 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-3)	2012-08-21	2021-06-30	No	No	Current
60505-2965-5	60505296505	500 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-5)	2012-08-21	2021-06-30	No	No	Current
60505-2965-6	60505296506	60 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-6)	2012-08-21	2021-06-30	No	No	Current
60505-2965-7	60505296507	120 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-7)	2012-08-21	0000-00-00	No	No	Current
60505-2965-8	60505296508	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-8)	2012-08-21	2021-06-30	No	No	Current
60505-2965-9	60505296509	90 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-9)	2012-08-21	2021-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mycophenolic Acid	American Health Packaging	2026-07-27	HUMAN PRESCRIPTION DRUG LABEL	10
Mycophenolic Acid	Major Pharmaceuticals	2026-06-15	HUMAN PRESCRIPTION DRUG LABEL	6
Mycophenolic Acid	Golden State Medical Supply, Inc.	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	13
Mycophenolic Acid	Apotex Corp	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	25
Mycophenolic Acid	REMEDYREPACK INC.	2023-03-23	HUMAN PRESCRIPTION DRUG LABEL	2
Mycophenolic Acid	AvPAK	2022-11-15	HUMAN PRESCRIPTION DRUG LABEL	3