mycophenolic acid

Product NDC: 68254-5001
11-digit product format: 682545001
Labeler code: 68254
Product ID: 68254-5001_47ef003d-aa2a-4b8e-9ab4-bba4cde21f09
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolic acid
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: CONCORD BIOTECH LIMITED
Application: ANDA211173
Marketing category: ANDA
Marketing start: 2019-12-13
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

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
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 · 74 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	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…`
2021-12-28 21:50 UTC	2021-12	A211173-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211173-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211173-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211173-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-12-13	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	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…`
2021-12-28 21:50 UTC	2021-12	A211173-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211173-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211173-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211173-002	AB	1	`87673890dc5c…`

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
a374549e-8afd-48fe-ae3f-368984689a2a	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
267b34ba-ace4-4048-9f21-d3c7ac983fc3	Product name	9	20210224
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68254-5001-1	mycophenolic acid	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120		10
68254-5001-2	mycophenolic acid	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68254-5001	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [CONCORD BIOTECH LIMITED]	9	Current NDC, Legacy NDC, 2 package rows	20240514_a374549e-8afd-48fe-ae3f-368984689a2a.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	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 ndc (product): 68254-5001

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	a374549e-8afd-48fe-ae3f-368984689a2a	10
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	a374549e-8afd-48fe-ae3f-368984689a2a	10
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	a374549e-8afd-48fe-ae3f-368984689a2a	10
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	a374549e-8afd-48fe-ae3f-368984689a2a	10
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	a374549e-8afd-48fe-ae3f-368984689a2a	10
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	a374549e-8afd-48fe-ae3f-368984689a2a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68254-5001-1	68254500101	120 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5001-1)	2019-12-13	0000-00-00	No	No	Current
68254-5001-2	68254500102	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5001-2)	2019-12-13	0000-00-00	No	No	Current