mycophenolic acid

Product NDC: 24979-161
11-digit product format: 249790161
Labeler code: 24979
Product ID: 24979-161_58cacd2f-3510-4ffb-b634-40325bca9e20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolic acid
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: TWi Pharmaceuticals, Inc.
Application: ANDA214289
Marketing category: ANDA
Marketing start: 2021-11-08
Marketing end: 0000-00-00
Substance: MYCOPHENOLATE SODIUM
Active strength: 360 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	24979-161		D	Discontinued by firm		2026-10-12
excluded package	package	24979-161	24979-161-44	D	Discontinued by firm		2026-10-12

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
A214289-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL			2021-11-03
A214289-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL			2021-11-03

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 · 70 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	A214289-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL		2021-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214289-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL		2021-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214289-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL		2021-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214289-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL		2021-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214289-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214289-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214289-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214289-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A214289-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214289-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214289-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214289-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214289-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214289-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214289-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214289-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214289-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214289-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214289-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214289-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214289-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214289-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214289-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214289-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214289-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214289-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214289-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214289-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214289-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A214289-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214289-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214289-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

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	Strength	SPL version
24979-161-44	mycophenolic acid	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24979-161-44	EA - Each	24979-161	e0e09d7d-cf21-4e7f-abac-b67dd7c94a8d	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24979-161	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [TWI PHARMACEUTICALS, INC.]	4	Legacy NDC, 1 package rows	20241009_f7c05bf9-816f-41e6-999d-bb3c7abd2627.zip

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	bc38bc5e-7f0a-4419-81ec-04726ce47421	12
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	bc38bc5e-7f0a-4419-81ec-04726ce47421	12
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	bc38bc5e-7f0a-4419-81ec-04726ce47421	12
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	bc38bc5e-7f0a-4419-81ec-04726ce47421	12
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	bc38bc5e-7f0a-4419-81ec-04726ce47421	12
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	bc38bc5e-7f0a-4419-81ec-04726ce47421	12
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	PSN	f7c05bf9-816f-41e6-999d-bb3c7abd2627	5
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	f7c05bf9-816f-41e6-999d-bb3c7abd2627	5
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	f7c05bf9-816f-41e6-999d-bb3c7abd2627	5
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	f7c05bf9-816f-41e6-999d-bb3c7abd2627	5
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	f7c05bf9-816f-41e6-999d-bb3c7abd2627	5
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	f7c05bf9-816f-41e6-999d-bb3c7abd2627	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24979-161-44	24979016144	120 TABLET, DELAYED RELEASE in 1 BOTTLE (24979-161-44)	2021-11-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
mycophenolic acid	PD-Rx Pharmaceuticals, Inc.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	13
mycophenolic acid	Upsher-Smith Laboratories, LLC \| TWi Pharmaceuticals, Inc. \| Bora Pharmaceutical Laboratories Inc. Zhongli Plant \| Apace Packaging LLC \| BORA PHARMACEUTICAL LABORATORIES INC.	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	5
mycophenolic acid	Major Pharmaceuticals	2024-01-03	HUMAN PRESCRIPTION DRUG LABEL	1