Mycophenolic Acid

Product NDC: 16729-261
11-digit product format: 167290261
Labeler code: 16729
Product ID: 16729-261_5c533c1f-cdfa-790b-e063-6394a90abc75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mycophenolic Acid
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA202555
Marketing category: ANDA
Marketing start: 2017-09-11
Substance: MYCOPHENOLATE SODIUM
Active strength: 180 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
A202555-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2017-08-23
A202555-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2017-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202555-001	AB
A202555-002	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 · 86 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	A202555-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202555-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202555-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202555-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202555-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202555-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202555-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202555-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202555-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202555-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A202555-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202555-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202555-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202555-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202555-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202555-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202555-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202555-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202555-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202555-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202555-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202555-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202555-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202555-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202555-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202555-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202555-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202555-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202555-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202555-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202555-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202555-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202555-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202555-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202555-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202555-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202555-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202555-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202555-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202555-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202555-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202555-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202555-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202555-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202555-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202555-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202555-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202555-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202555-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202555-002	AB	1	`f41ea6bd6efb…`

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	180 mg/1

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
16729-261-29	Mycophenolic Acid	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-261-29	EA - Each	16729-261	fe29a768-77f4-44e2-a798-fc49f6cbc2b4	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-261	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [ACCORD HEALTHCARE INC.]	7	Current NDC, Legacy NDC, 1 package rows	20240118_dc24aa15-330c-4698-872f-159d7e582b4b.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	dc24aa15-330c-4698-872f-159d7e582b4b	7
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	dc24aa15-330c-4698-872f-159d7e582b4b	7
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	dc24aa15-330c-4698-872f-159d7e582b4b	7
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	dc24aa15-330c-4698-872f-159d7e582b4b	7
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	dc24aa15-330c-4698-872f-159d7e582b4b	7
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	dc24aa15-330c-4698-872f-159d7e582b4b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-261-29	16729026129	120 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-261-29)	2017-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mycophenolic Acid	Accord Healthcare Inc. \| Intas Pharmaceuticals Ltd	2026-09-25	HUMAN PRESCRIPTION DRUG LABEL	8