Myfortic
- Product NDC
- 0078-0386
- 11-digit product format
- 000780386
- Labeler code
- 0078
- Product ID
- 0078-0386_c5665f04-bf64-4cc7-b98b-171a8f57155b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mycophenolic acid
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA050791
- Marketing category
- NDA
- Marketing start
- 2004-02-27
- 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 |
|---|---|---|---|---|---|---|---|
| N050791-001 | MYFORTIC | MYCOPHENOLATE SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 |
| N050791-002 | MYFORTIC | MYCOPHENOLATE SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050791-001 | AB |
| N050791-002 | 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 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050791-001 | MYFORTIC | 180MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050791-002 | MYFORTIC | 360MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050791-001 | MYFORTIC | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2004-02-27 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050791-002 | MYFORTIC | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2004-02-27 | 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 | N050791-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050791-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050791-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050791-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050791-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050791-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050791-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050791-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050791-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050791-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050791-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050791-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050791-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050791-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050791-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050791-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050791-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050791-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050791-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050791-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050791-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050791-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050791-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050791-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050791-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050791-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050791-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050791-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050791-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050791-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050791-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050791-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050791-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050791-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050791-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050791-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050791-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050791-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050791-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050791-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Myfortic
- 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 |
|---|---|
| eed26501-890d-4ff6-88e7-6dbea4726e53 | 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 |
|---|---|---|---|---|---|---|
| 0078-0386-66 | Myfortic | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | 35 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-0386-66 | EA - Each | 0078-0386 | f1fe1684-896e-4201-8e60-c33d16fba3a7 | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| Myfortic | MYCOPHENOLIC ACID | Novartis Pharmaceuticals Corporation | eed26501-890d-4ff6-88e7-6dbea4726e53 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | 050791 NDA050791 0078-0386 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | PSN | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | PSN | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 616450 | Myfortic 180 MG Delayed Release Oral Tablet | PSN | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 616449 | Myfortic 360 MG Delayed Release Oral Tablet | PSN | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 616450 | mycophenolic acid 180 MG Delayed Release Oral Tablet [Myfortic] | SBD | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 616449 | mycophenolic acid 360 MG Delayed Release Oral Tablet [Myfortic] | SBD | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | SCD | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | SCD | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 485020 | mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet | SY | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 485023 | mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet | SY | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 616450 | Myfortic 180 MG Delayed Release Oral Tablet | SY | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
| 616449 | Myfortic 360 MG Delayed Release Oral Tablet | SY | eed26501-890d-4ff6-88e7-6dbea4726e53 | 35 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0078-0386-66 | 00078038666 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0386-66) | 2004-02-27 | 0000-00-00 | No | No | Current |