MYCOPHENOLATE MOFETIL

Product NDC: 70748-186
Requested package NDC: 70748-186-01
11-digit product format: 707480186
Labeler code: 70748
Product ID: 70748-186_c899d996-beb5-455f-9f83-0d7516e139c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mycophenolate mofetil
Dosage form: CAPSULE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA210181
Marketing category: ANDA
Marketing start: 2019-10-01
Marketing end: 0000-00-00
Substance: MYCOPHENOLATE MOFETIL
Active strength: 250 mg/1
Pharmacologic classes: Antimetabolite Immunosuppressant [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70748-186	70748-186-01	D	Discontinued by firm		2026-08-03

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 · 2 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	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70748-186	70748-186-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70748-186	70748-186-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A210181-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB		2019-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210181-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210181-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2019-01-08	`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	A210181-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210181-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210181-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210181-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210181-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210181-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210181-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210181-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210181-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210181-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210181-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210181-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210181-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210181-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210181-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210181-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210181-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210181-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210181-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210181-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210181-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210181-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210181-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210181-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210181-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210181-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210181-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210181-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210181-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210181-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210181-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210181-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210181-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210181-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210181-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210181-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210181-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210181-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210181-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210181-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70748-186-01	EA - Each	70748-186	c48b035d-d452-4849-82c5-3467ec263147	1	2019-10-07
70748-186-02	EA - Each	70748-186	56e76b05-d8d2-418c-9262-e6a44b62522c	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70748-186	MYCOPHENOLATE MOFETIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]	12	Legacy NDC	20241018_9835762c-a1ec-4f7e-8d44-2e08303e503e.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	REMEDYREPACK INC.	d203775c-bf36-460c-bacf-3ab2348a514f	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210181 application number: ANDA210181
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	Advagen Pharma Limited	a15c26d8-5a27-48ba-a669-8546803d901f	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210181 application number: ANDA210181
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	CONCORD BIOTECH LIMITED	64ac00ee-298c-49cf-a91c-78019a0d014d	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210181 application number: ANDA210181

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70748-186-01	70748018601	100 CAPSULE in 1 BOTTLE (70748-186-01)	100 capsule	2019-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MYCOPHENOLATE MOFETIL	Lupin Pharmaceuticals, Inc. \| CONCORD BIOTECH LIMITED	2024-10-16	HUMAN PRESCRIPTION DRUG LABEL	12