mycophenolate mofetil

Product NDC: 72485-415
11-digit product format: 724850415
Labeler code: 72485
Product ID: 72485-415_42edff88-f01d-0908-e063-6294a90a3b0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolate mofetil
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: ARMAS PHARMACEUTICALS INC
Application: ANDA216390
Marketing category: ANDA
Marketing start: 2023-07-06
Substance: MYCOPHENOLATE MOFETIL
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 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
A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP		2022-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216390-001	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
2026-08-18 06:07:40	2026-07	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216390-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2022-12-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216390-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216390-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216390-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216390-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216390-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216390-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216390-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216390-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216390-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216390-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216390-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216390-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216390-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216390-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216390-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216390-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216390-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216390-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216390-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216390-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216390-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216390-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216390-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216390-001	AP	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216390-001	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	500 mg/20mL

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 · 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
ffcc237c-f31b-77b8-e053-6294a90a603e	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
72485-415-04	mycophenolate mofetil	4 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	4		4
72485-415-04	mycophenolate mofetil	20 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	20		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72485-415-04	EA - Each	72485-415	8f2bdb0e-0b92-44b5-a488-29bc0cf1cfc3	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72485-415	MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ARMAS PHARMACEUTICALS INC]	3	Current NDC, 2 package rows	20250523_ffcc237c-f31b-77b8-e053-6294a90a603e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	ONESOURCE SPECIALTY PHARMA LIMITED	461a252f-ff81-4e08-b256-a497b14835fa	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216390 application number: ANDA216390
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	ARMAS PHARMACEUTICALS INC	ffcc237c-f31b-77b8-e053-6294a90a603e	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216390 application number: ANDA216390 ndc (product): 72485-415

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
311881	mycophenolate mofetil 500 MG Injection	PSN	ffcc237c-f31b-77b8-e053-6294a90a603e	4
311881	mycophenolate mofetil 500 MG Injection	SCD	ffcc237c-f31b-77b8-e053-6294a90a603e	4
311881	mycophenolate mofetil (as mycophenolate mofetil hydrochloride) 500 MG Injection	SY	ffcc237c-f31b-77b8-e053-6294a90a603e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72485-415-04	72485041504	4 VIAL in 1 CARTON (72485-415-04) / 20 mL in 1 VIAL	4 vial	2023-07-06	No	No	Current