CellCept

Product NDC: 0004-0298
11-digit product format: 000040298
Labeler code: 0004
Product ID: 0004-0298_ad799779-cc87-4d12-9836-74375149b84b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mycophenolate Mofetil hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Genentech, Inc.
Application: NDA050758
Marketing category: NDA
Marketing start: 1998-08-12
Substance: MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Active strength: 500 mg/20mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050758-001	CELLCEPT	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050758-001	AP

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050758-001	CELLCEPT	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N050758-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050758-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050758-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050758-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050758-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050758-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050758-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050758-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050758-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050758-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050758-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050758-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050758-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050758-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050758-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050758-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050758-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050758-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050758-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050758-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050758-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050758-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050758-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050758-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050758-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050758-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050758-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050758-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050758-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050758-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050758-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050758-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050758-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050758-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050758-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050758-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050758-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050758-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050758-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050758-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: CellCept
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9242ECW6R0	Internal UNII lookup
UXH81S8ZVB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199058	Internal RxNorm lookup
200060	Internal RxNorm lookup
213394	Internal RxNorm lookup
311880	Internal RxNorm lookup
311881	Internal RxNorm lookup
616435	Internal RxNorm lookup
616444	Internal RxNorm lookup
616447	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
37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
267b34ba-ace4-4048-9f21-d3c7ac983fc3	Product name	9	20210224
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0004-0298-09	2024-01-30	C162847	48780-1	1030e365-26ba-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CELLCEPT ® safely and effectively. See full prescribing information for CELLCEPT ® CELLCEPT ® (mycophenolate mofetil) capsules, for oral use CELLCEPT ® (mycophenolate mofetil) tablets, for oral use CELLCEPT ® Oral Suspension (mycophenolate mofetil), for oral suspension CELLCEPT ® Intravenous (mycophenolate mofetil) for injection, for intravenous use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0004-0298-09	CellCept	4 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	4		50
0004-0298-09	CellCept	20 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	20		50

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0004-0298-09	EA - Each	0004-0298	b6641e6a-0583-450d-a678-bcd4ee61593c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mycophenolate Mofetil	ACTIVE INGREDIENT	9242ECW6R0	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Mycophenolate Mofetil hydrochloride	ACTIVE INGREDIENT	UXH81S8ZVB	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
mycophenolic acid	ACTIVE MOIETY	HU9DX48N0T	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Alcohol	INACTIVE INGREDIENT	3K9958V90M	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
ammonia	INACTIVE INGREDIENT	5138Q19F1X	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
aspartame	INACTIVE INGREDIENT	Z0H242BBR1	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
FD&C blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
fruit, unspecified	INACTIVE INGREDIENT	C2AIY4ERZC	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
gelatin	INACTIVE INGREDIENT	2G86QN327L	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
lecithin, soybean	INACTIVE INGREDIENT	1DI56QDM62	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Povidone K90	INACTIVE INGREDIENT	RDH86HJV5Z	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
shellac	INACTIVE INGREDIENT	46N107B71O	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
sorbitol	INACTIVE INGREDIENT	506T60A25R	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
Water	INACTIVE INGREDIENT	059QF0KO0R	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0004-0298	CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]	47	Current NDC, Legacy NDC, 2 package rows	20250522_37241e87-4af4-4dc3-a1aa-ea6f20d8dc40.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CellCept	MYCOPHENOLATE MOFETIL	Genentech, Inc.	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050758 application number: NDA050758 ndc (product): 0004-0298

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UXH81S8ZVB	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	116680-01-4	MYCOPHENOLATE MOFETIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
616444	CellCept 200 MG in 1 mL Oral Suspension	PSN	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616447	CellCept 250 MG Oral Capsule	PSN	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
213394	CellCept 500 MG Injection	PSN	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616435	CellCept 500 MG Oral Tablet	PSN	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
311880	mycophenolate mofetil 200 MG in 1 mL Oral Suspension	PSN	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
199058	mycophenolate mofetil 250 MG Oral Capsule	PSN	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
311881	mycophenolate mofetil 500 MG Injection	PSN	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
200060	mycophenolate mofetil 500 MG Oral Tablet	PSN	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616444	mycophenolate mofetil 200 MG/ML Oral Suspension [Cellcept]	SBD	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616447	mycophenolate mofetil 250 MG Oral Capsule [Cellcept]	SBD	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
213394	mycophenolate mofetil 500 MG Injection [Cellcept]	SBD	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616435	mycophenolate mofetil 500 MG Oral Tablet [Cellcept]	SBD	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
311880	mycophenolate mofetil 200 MG/ML Oral Suspension	SCD	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
199058	mycophenolate mofetil 250 MG Oral Capsule	SCD	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
311881	mycophenolate mofetil 500 MG Injection	SCD	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
200060	mycophenolate mofetil 500 MG Oral Tablet	SCD	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616447	Cellcept (as mycophenolate mofetil) 250 MG Oral Capsule	SY	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616444	Cellcept 200 MG per 1 ML Oral Suspension	SY	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616444	Cellcept 200 MG/ML Oral Suspension	SY	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616447	Cellcept 250 MG Oral Capsule	SY	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
213394	Cellcept 500 MG Injection	SY	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
616435	Cellcept 500 MG Oral Tablet	SY	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
311881	mycophenolate mofetil (as mycophenolate mofetil hydrochloride) 500 MG Injection	SY	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50
311880	mycophenolate mofetil 200 MG per 1 ML Oral Suspension	SY	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	50

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0004-0298-09	00004029809	4 VIAL in 1 CARTON (0004-0298-09) / 20 mL in 1 VIAL	4 vial	1998-08-12	0000-00-00	No	No	Current