mycophenolic acid

Product NDC: 85972-162
11-digit product format: 859720162
Labeler code: 85972
Product ID: 85972-162_255231b8-9564-4542-9449-9dcb8c8dd3e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolic acid
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Stellon Biotech Inc.
Application: ANDA211173
Marketing category: ANDA
Marketing start: 2026-09-11
Substance: MYCOPHENOLATE SODIUM
Active strength: 360 mg/1
Pharmacologic classes: Antimetabolite Immunosuppressant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A211173-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2019-12-13
A211173-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2019-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211173-001	AB
A211173-002	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 2 · 78 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	A211173-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211173-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211173-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211173-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211173-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211173-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211173-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211173-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`bb7c543d1eb4…`

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
2026-09-14 22:38:34	2026-08	A211173-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211173-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211173-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211173-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211173-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211173-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211173-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211173-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211173-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211173-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211173-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211173-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211173-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211173-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211173-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211173-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211173-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211173-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211173-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211173-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211173-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211173-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211173-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211173-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211173-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211173-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211173-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211173-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211173-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211173-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211173-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211173-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211173-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211173-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211173-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211173-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211173-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211173-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211173-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211173-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: mycophenolic acid
Listing expiration: 2027-12-31

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
4b153bb3-fb7a-472d-b73e-e630e50c5633	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mycophenolic acid	MYCOPHENOLIC ACID	Stellon Biotech Inc.	4b153bb3-fb7a-472d-b73e-e630e50c5633	2026-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211173 application number: ANDA211173 ndc (product): 85972-162
mycophenolic acid	MYCOPHENOLIC ACID	Advagen Pharma Limited	a2c1a135-67e7-4052-bbb9-b6135d45ff75	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211173 application number: ANDA211173
mycophenolic acid	MYCOPHENOLIC ACID	CONCORD BIOTECH LIMITED	a374549e-8afd-48fe-ae3f-368984689a2a	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211173 application number: ANDA211173

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85972-162-12	85972016212	120 TABLET, DELAYED RELEASE in 1 BOTTLE (85972-162-12)	2026-09-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
mycophenolic acid	Stellon Biotech Inc. \| CONCORD BIOTECH LIMITED	2026-02-28	HUMAN PRESCRIPTION DRUG LABEL	1