Mycophenolic Acid

Product NDC: 70377-127
11-digit product format: 703770127
Labeler code: 70377
Product ID: 70377-127_3fff88d0-af7a-defa-0465-70be67431a57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mycophenolic Acid
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Biocon Pharma Inc.
Application: ANDA217031
Marketing category: ANDA
Marketing start: 2024-09-30
Substance: MYCOPHENOLATE SODIUM
Active strength: 360 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217031-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2023-11-29
A217031-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2023-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217031-001	AB
A217031-002	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.

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	A217031-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217031-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217031-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217031-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217031-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217031-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217031-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217031-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2023-11-29	`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	A217031-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217031-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217031-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217031-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217031-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217031-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217031-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217031-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217031-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217031-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217031-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217031-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217031-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217031-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217031-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217031-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217031-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217031-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217031-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217031-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217031-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217031-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217031-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217031-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217031-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217031-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217031-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217031-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217031-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217031-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217031-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217031-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217031-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217031-002	AB	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217031-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217031-002	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MYCOPHENOLATE SODIUM	360 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
7f8d259a-9880-bb8b-2738-b3c6c1edf152	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
70377-127-11	Mycophenolic Acid	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70377-127-11	EA - Each	70377-127	e50a6680-2c04-4cbe-b228-7f29b313f8a2	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70377-127	MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [BIOCON PHARMA INC.]	1	Current NDC, 1 package rows	20241001_7f8d259a-9880-bb8b-2738-b3c6c1edf152.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
Mycophenolic Acid	MYCOPHENOLIC ACID	Biocon Pharma Inc.	7f8d259a-9880-bb8b-2738-b3c6c1edf152	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217031 application number: ANDA217031 ndc (product): 70377-127

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	7f8d259a-9880-bb8b-2738-b3c6c1edf152	1
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	PSN	7f8d259a-9880-bb8b-2738-b3c6c1edf152	1
485020	mycophenolic acid 180 MG Delayed Release Oral Tablet	SCD	7f8d259a-9880-bb8b-2738-b3c6c1edf152	1
485023	mycophenolic acid 360 MG Delayed Release Oral Tablet	SCD	7f8d259a-9880-bb8b-2738-b3c6c1edf152	1
485020	mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet	SY	7f8d259a-9880-bb8b-2738-b3c6c1edf152	1
485023	mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet	SY	7f8d259a-9880-bb8b-2738-b3c6c1edf152	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70377-127-11	70377012711	120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-127-11)	2024-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mycophenolic Acid	Biocon Pharma Inc. \| ACME GENERICS PRIVATE LIMITED	2024-08-27	HUMAN PRESCRIPTION DRUG LABEL	1