Mycophenolate mofetil

Product NDC: 42543-988
11-digit product format: 425430988
Labeler code: 42543
Product ID: 42543-988_f2e4fa33-6e09-487c-aa77-bb4937983db6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mycophenolate mofetil
Dosage form: CAPSULE
Route: ORAL
Labeler: Strides Pharma Inc.
Application: ANDA090055
Marketing category: ANDA
Marketing start: 2025-02-28
Substance: MYCOPHENOLATE MOFETIL
Active strength: 250 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090055-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB		2010-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090055-001	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 · 43 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	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A090055-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090055-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090055-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090055-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090055-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090055-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090055-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090055-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090055-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090055-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090055-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090055-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090055-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090055-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090055-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090055-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090055-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090055-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090055-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090055-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090055-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090055-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090055-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090055-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090055-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090055-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090055-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090055-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090055-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090055-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090055-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090055-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090055-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090055-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090055-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090055-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090055-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090055-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090055-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090055-001	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: Mycophenolate mofetil
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MYCOPHENOLATE MOFETIL	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9242ECW6R0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199058	Internal RxNorm lookup
200060	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
9d8c09fc-1df2-4f39-8e1a-c4b296d1a260	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
42543-988-06	Mycophenolate mofetil	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		1
42543-988-07	Mycophenolate mofetil	500 in 1 BOTTLE, PLASTIC	CAPSULE	500		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-988-07	EA - Each	42543-988	3a60a6fc-3f87-40c8-97a0-e0919cde61ae	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42543-988	MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES PHARMA INC.]	1	Current NDC, 2 package rows	20250228_9d8c09fc-1df2-4f39-8e1a-c4b296d1a260.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Strides Pharma Inc.	9d8c09fc-1df2-4f39-8e1a-c4b296d1a260	2026-09-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090055 application number: ANDA090055 ndc (product): 42543-988
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	REMEDYREPACK INC.	77a75d5b-a90d-4ee5-aa8a-6da97d130357	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090055 application number: ANDA090055
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	3ac54299-15cc-4c7a-8831-60c15a859b85	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090055 application number: ANDA090055
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Strides Pharma Science Limited	32dd890a-cfe3-4129-bce6-1d3dbe38e4f3	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090055 application number: ANDA090055
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	AvKARE	339a10c4-e442-de9e-e063-6294a90a6208	2025-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090055 application number: ANDA090055

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9242ECW6R0	MYCOPHENOLATE MOFETIL	128794-94-5	MYCOPHENOLATE MOFETIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199058	mycophenolate mofetil 250 MG Oral Capsule	PSN	339a10c4-e442-de9e-e063-6294a90a6208	1
199058	mycophenolate mofetil 250 MG Oral Capsule	PSN	9d8c09fc-1df2-4f39-8e1a-c4b296d1a260	1
200060	mycophenolate mofetil 500 MG Oral Tablet	PSN	339a10c4-e442-de9e-e063-6294a90a6208	1
200060	mycophenolate mofetil 500 MG Oral Tablet	PSN	9d8c09fc-1df2-4f39-8e1a-c4b296d1a260	1
199058	mycophenolate mofetil 250 MG Oral Capsule	SCD	339a10c4-e442-de9e-e063-6294a90a6208	1
199058	mycophenolate mofetil 250 MG Oral Capsule	SCD	9d8c09fc-1df2-4f39-8e1a-c4b296d1a260	1
200060	mycophenolate mofetil 500 MG Oral Tablet	SCD	339a10c4-e442-de9e-e063-6294a90a6208	1
200060	mycophenolate mofetil 500 MG Oral Tablet	SCD	9d8c09fc-1df2-4f39-8e1a-c4b296d1a260	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42543-988-06	42543098806	100 in 1 BOTTLE, PLASTIC					Historical
42543-988-07	42543098807	500 CAPSULE in 1 BOTTLE, PLASTIC (42543-988-07)	500 capsule	2025-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mycophenolate mofetil	Strides Pharma Inc.	2026-09-07	HUMAN PRESCRIPTION DRUG LABEL	3
Mycophenolate mofetil	AvKARE	2025-04-25	HUMAN PRESCRIPTION DRUG LABEL	1