Mycophenolic Acid
- Product NDC
- 68084-918
- 11-digit product format
- 680840918
- Labeler code
- 68084
- Product ID
- 68084-918_27ea2d9a-52b6-818e-e063-6394a90a52c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolic Acid
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA091558
- Marketing category
- ANDA
- Marketing start
- 2015-04-02
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091558-001 | MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | |
| A091558-002 | MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091558-001 | AB |
| A091558-002 | 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091558-001 | MYCOPHENOLATE SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091558-002 | MYCOPHENOLATE SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091558-001 | MYCOPHENOLATE SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091558-002 | MYCOPHENOLATE SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091558-001 | MYCOPHENOLIC ACID | 180MG | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091558-002 | MYCOPHENOLIC ACID | 360MG | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091558-001 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-08-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091558-002 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-08-19 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091558-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091558-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091558-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091558-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091558-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091558-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091558-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091558-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091558-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091558-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091558-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091558-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091558-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091558-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091558-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091558-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091558-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091558-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091558-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091558-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091558-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091558-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091558-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091558-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091558-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091558-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091558-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091558-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091558-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091558-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091558-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091558-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091558-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091558-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091558-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091558-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091558-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091558-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091558-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091558-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mycophenolic Acid
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MYCOPHENOLATE SODIUM | 360 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WX877SQI1G | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 26b31126-4262-4a15-8a16-234c86763176 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68084-918-25 | Mycophenolic Acid | 30 in 1 BOX, UNIT-DOSE | TABLET, DELAYED RELEASE | 30 | 9 | |
| 68084-918-95 | Mycophenolic Acid | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68084-918-25 | EA - Each | 68084-918 | fcaf8229-119e-404b-8808-d7ce89b061ef | 1 | 2015-04-03 |
| 68084-918-95 | EA - Each | 68084-918 | d34cbade-6bee-476f-9739-4d00e721ee6f | 1 | 2015-04-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mycophenolic Acid | MYCOPHENOLIC ACID | American Health Packaging | 26b31126-4262-4a15-8a16-234c86763176 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 091558 ANDA091558 68084-918 |
| Mycophenolic Acid | MYCOPHENOLIC ACID | Major Pharmaceuticals | 93763b39-ba21-449b-bdc5-254ba57154e4 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 091558 ANDA091558 |
| Mycophenolic Acid | MYCOPHENOLIC ACID | Golden State Medical Supply, Inc. | 3a0a6ef4-fb2c-47be-82d7-d2675059c45b | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 091558 ANDA091558 |
| Mycophenolic Acid | MYCOPHENOLIC ACID | Apotex Corp | c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0 | 2025-07-23 | Boxed warning, Warnings, Adverse reactions | 091558 ANDA091558 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | PSN | 26b31126-4262-4a15-8a16-234c86763176 | 9 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | PSN | 26b31126-4262-4a15-8a16-234c86763176 | 9 |
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | SCD | 26b31126-4262-4a15-8a16-234c86763176 | 9 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | SCD | 26b31126-4262-4a15-8a16-234c86763176 | 9 |
| 485020 | mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet | SY | 26b31126-4262-4a15-8a16-234c86763176 | 9 |
| 485023 | mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet | SY | 26b31126-4262-4a15-8a16-234c86763176 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68084-918-25 | 68084091825 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-918-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68084-918-95) | 30 blister pack | 2015-04-02 | 0000-00-00 | No | No | Current |
| 68084-918-95 | 68084091895 | 1 in 1 BLISTER PACK | Historical |