Mycophenolate Mofetil

Product NDC: 54288-141
Requested package NDC: 54288-141-04
11-digit product format: 542880141
Labeler code: 54288
Product ID: 54288-141_1a8abd3a-6834-4468-a443-ca95e795b17d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mycophenolate Mofetil hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: BPI Labs LLC
Application: ANDA214283
Marketing category: ANDA
Marketing start: 2023-03-08
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54288-141	54288-141-04	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54288-141	54288-141-04	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54288-141	54288-141-04	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP		2023-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214283-001	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.

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	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214283-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-06-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214283-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214283-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214283-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214283-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214283-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214283-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214283-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214283-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214283-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214283-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214283-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214283-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214283-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214283-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214283-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214283-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214283-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214283-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214283-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214283-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214283-001	AP	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214283-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mycophenolate Mofetil
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 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311881	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
32001417-130d-4c08-8e63-94ba3627ce5f	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
54288-141-04	2025-02-14	C162847	48780-1	2cef2736-a333-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL FOR INJECTION safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL FOR INJECTION. MYCOPHENOLATE MOFETIL for injection, for intravenous use Initial U.S. Approval: 1995
54288-141-04	2025-01-30	C162847	48780-1	2cef2736-a333-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL FOR INJECTION safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL FOR INJECTION. 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
54288-141-04	Mycophenolate Mofetil	20 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	20		5
54288-141-04	Mycophenolate Mofetil	4 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	4		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54288-141-04	EA - Each	54288-141	18f29f2f-ce26-437b-a99d-e588019942e3	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54288-141	MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BPI LABS LLC]	4	Current NDC, 2 package rows	20250216_32001417-130d-4c08-8e63-94ba3627ce5f.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
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	BPI Labs LLC	32001417-130d-4c08-8e63-94ba3627ce5f	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214283 application number: ANDA214283 ndc (package): 54288-141-04 ndc (product): 54288-141 ndc11 (package): 54288014104

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
311881	mycophenolate mofetil 500 MG Injection	PSN	32001417-130d-4c08-8e63-94ba3627ce5f	5
311881	mycophenolate mofetil 500 MG Injection	SCD	32001417-130d-4c08-8e63-94ba3627ce5f	5
311881	mycophenolate mofetil (as mycophenolate mofetil hydrochloride) 500 MG Injection	SY	32001417-130d-4c08-8e63-94ba3627ce5f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
54288-141-04	54288014104	4 VIAL in 1 CARTON (54288-141-04) / 20 mL in 1 VIAL	4 vial	2023-03-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mycophenolate Mofetil	BPI Labs LLC \| Bioindustria Laboratorio Italiano Medicinali S.p.A	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	5