MYCOPHENOLIC ACID

Product NDC: 67877-426
11-digit product format: 678770426
Labeler code: 67877
Product ID: 67877-426_27fbf61b-de1e-479a-9d04-6dc1d48f3148
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MYCOPHENOLIC ACID
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA208315
Marketing category: ANDA
Marketing start: 2021-09-24
Substance: MYCOPHENOLATE SODIUM
Active strength: 180 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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208315-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2021-09-23
A208315-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2021-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208315-001	AB
A208315-002	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 · 66 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	A208315-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208315-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208315-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208315-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208315-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208315-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-09-23	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A208315-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208315-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208315-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208315-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208315-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208315-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208315-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208315-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208315-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208315-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208315-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208315-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208315-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208315-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208315-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208315-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208315-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208315-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208315-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208315-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208315-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208315-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208315-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208315-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208315-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208315-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208315-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208315-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208315-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208315-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208315-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208315-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208315-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208315-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208315-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208315-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208315-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208315-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208315-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208315-002	AB	1	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: MYCOPHENOLIC ACID
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MYCOPHENOLATE SODIUM	180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WX877SQI1G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485020	Internal RxNorm lookup
485023	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
2d9975e1-baee-4b0c-83de-8a0a92c5d075	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	SPL version
67877-426-05	MYCOPHENOLIC ACID	500 in 1 BOTTLE	TABLET, DELAYED RELEASE	500	16
67877-426-12	MYCOPHENOLIC ACID	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120	16
67877-426-33	MYCOPHENOLIC ACID	10 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	10	16
67877-426-38	MYCOPHENOLIC ACID	10 in 1 CARTON	TABLET, DELAYED RELEASE	10	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-426-12	EA - Each	67877-426	39c5aa5b-1253-4d4c-9e6d-8fe55b532dba	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-426	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	11	Current NDC, Legacy NDC, 4 package rows	20230329_2d9975e1-baee-4b0c-83de-8a0a92c5d075.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	Major Pharmaceuticals	6b170816-6e5c-400c-b97b-82bbbb7d4925	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208315 application number: ANDA208315
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	Ascend Laboratories, LLC	8617bd03-6da7-48ca-b430-6dfc38f19e2b	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208315 application number: ANDA208315
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	Ascend Laboratories, LLC	2d9975e1-baee-4b0c-83de-8a0a92c5d075	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208315 application number: ANDA208315 ndc (product): 67877-426
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	REMEDYREPACK INC.	bc98d9a1-b4e3-4085-a8ba-d3313246658a	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208315 application number: ANDA208315
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	A-S Medication Solutions	8b73dc87-c611-4bcb-8852-532eb388cb2e	2023-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208315 application number: ANDA208315

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WX877SQI1G	MYCOPHENOLATE SODIUM	37415-62-6	MYCOPHENOLATE SODIUM
HU9DX48N0T	MYCOPHENOLIC ACID	24280-93-1	MYCOPHENOLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	PSN	2d9975e1-baee-4b0c-83de-8a0a92c5d075	16
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	2d9975e1-baee-4b0c-83de-8a0a92c5d075	16
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	2d9975e1-baee-4b0c-83de-8a0a92c5d075	16
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	2d9975e1-baee-4b0c-83de-8a0a92c5d075	16
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	2d9975e1-baee-4b0c-83de-8a0a92c5d075	16
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	2d9975e1-baee-4b0c-83de-8a0a92c5d075	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-426-05	67877042605	500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-426-05)		2021-09-24	0000-00-00	No	No	Current
67877-426-12	67877042612	120 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-426-12)		2021-09-24	0000-00-00	No	No	Current
67877-426-33	67877042633	10 in 1 BLISTER PACK						Historical
67877-426-38	67877042638	10 BLISTER PACK in 1 CARTON (67877-426-38) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-426-33)	10 blister pack	2021-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MYCOPHENOLIC ACID	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2026-03-25	Human Prescription Drug Label	16