mycophenolic acid

Product NDC: 24979-161
11-digit product format: 249790161
Labeler code: 24979
Product ID: 24979-161_1dc7a361-08d4-47f5-a74c-6ad4bb35a976
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolic acid
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA214289
Marketing category: ANDA
Marketing start: 2021-11-08
Marketing end: 2026-09-30
Substance: MYCOPHENOLATE SODIUM
Active strength: 360 mg/1
Pharmacologic classes: Antimetabolite Immunosuppressant [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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
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 · 66 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	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…`
2021-12-28 21:50 UTC	2021-12	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214289-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214289-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-03	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A214289-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214289-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214289-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214289-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214289-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214289-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214289-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214289-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214289-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214289-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214289-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214289-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214289-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214289-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214289-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214289-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214289-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214289-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214289-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214289-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214289-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214289-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214289-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214289-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214289-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214289-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214289-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214289-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214289-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214289-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214289-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214289-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214289-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214289-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214289-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214289-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214289-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214289-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214289-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214289-002	AB	1	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: mycophenolic acid

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MYCOPHENOLATE SODIUM	360 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
f7c05bf9-816f-41e6-999d-bb3c7abd2627	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	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	Current NDC, Legacy NDC, 1 package rows	20241009_f7c05bf9-816f-41e6-999d-bb3c7abd2627.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mycophenolic acid	MYCOPHENOLIC ACID	PD-Rx Pharmaceuticals, Inc.	bc38bc5e-7f0a-4419-81ec-04726ce47421	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214289 application number: ANDA214289
mycophenolic acid	MYCOPHENOLIC ACID	Upsher-Smith Laboratories, LLC	f7c05bf9-816f-41e6-999d-bb3c7abd2627	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214289 application number: ANDA214289 ndc (product): 24979-161

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	2026-09-30	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