Mycophenolate Mofetil

Product NDC: 50268-558
11-digit product format: 502680558
Labeler code: 50268
Product ID: 50268-558_47e7bafd-1b50-c454-e063-6394a90a6868
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mycophenolate Mofetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA091249
Marketing category: ANDA
Marketing start: 2023-05-15
Substance: MYCOPHENOLATE MOFETIL
Active strength: 500 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 42.

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
A091249-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB		2011-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091249-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091249-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2011-11-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091249-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091249-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091249-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091249-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091249-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091249-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091249-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091249-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091249-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091249-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091249-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091249-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091249-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091249-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091249-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091249-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091249-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091249-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091249-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091249-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091249-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091249-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091249-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091249-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091249-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091249-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091249-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091249-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091249-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091249-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091249-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091249-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091249-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091249-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091249-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091249-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091249-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091249-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091249-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091249-001	AB	1	`e64feba35796…`

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	500 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
fbbe6521-0e21-5372-e053-6394a90ae5e4	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
50268-558-11	Mycophenolate Mofetil	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2
50268-558-15	Mycophenolate Mofetil	50 in 1 BOX	TABLET, FILM COATED	50		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-558-11	EA - Each	50268-558	8ed0594e-d494-4e45-96cb-4a8bdd3da820	1	2023-06-06
50268-558-15	EA - Each	50268-558	570e2444-93bd-430d-b00f-cebb2ca20e08	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-558	MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [AVPAK]	1	Current NDC, 2 package rows	20230517_fbbe6521-0e21-5372-e053-6394a90ae5e4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	A-S Medication Solutions	b4170ad9-67f0-42ea-b694-6b80824a607a	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091249 application number: ANDA091249
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Ascend Laboratories, LLC	9f84ea84-2d8b-4d91-a33f-7dfb5df937dc	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091249 application number: ANDA091249
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	AvPAK	fbbe6521-0e21-5372-e053-6394a90ae5e4	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091249 application number: ANDA091249 ndc (product): 50268-558

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	fbbe6521-0e21-5372-e053-6394a90ae5e4	2
200060	mycophenolate mofetil 500 MG Oral Tablet	PSN	fbbe6521-0e21-5372-e053-6394a90ae5e4	2
199058	mycophenolate mofetil 250 MG Oral Capsule	SCD	fbbe6521-0e21-5372-e053-6394a90ae5e4	2
200060	mycophenolate mofetil 500 MG Oral Tablet	SCD	fbbe6521-0e21-5372-e053-6394a90ae5e4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-558-11	50268055811	1 in 1 BLISTER PACK					Historical
50268-558-15	50268055815	50 BLISTER PACK in 1 BOX (50268-558-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-558-11)	50 blister pack	2023-05-15	No	No	Current