Mycophenolic Acid
- Product NDC
- 0378-4202
- Requested package NDC
- 0378-4202-78
- 11-digit product format
- 003784202
- Labeler code
- 0378
- Product ID
- 0378-4202_75783cee-b6a7-46fb-b605-8973200a3eb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolic Acid
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA091248
- Marketing category
- ANDA
- Marketing start
- 2014-01-08
- Marketing end
- 2023-09-30
- Substance
- MYCOPHENOLIC ACID
- Active strength
- 360 mg/1
- Pharmacologic classes
- Antimetabolite Immunosuppressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0378-4202 | 0378-4202-78 | D | Discontinued by firm | 2026-08-11 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091248-001 | MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | 2014-01-08 | ||
| A091248-002 | MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | 2014-01-08 |
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 | A091248-001 | MYCOPHENOLATE SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | 2014-01-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091248-002 | MYCOPHENOLATE SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | 2014-01-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091248-001 | MYCOPHENOLATE SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091248-002 | MYCOPHENOLATE SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091248-001 | MYCOPHENOLIC ACID | 360MG | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091248-002 | MYCOPHENOLIC ACID | 180MG | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091248-001 | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091248-002 | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2014-01-08 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091248-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091248-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091248-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091248-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091248-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091248-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091248-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091248-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091248-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091248-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091248-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091248-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091248-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091248-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091248-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091248-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091248-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091248-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091248-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091248-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091248-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091248-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091248-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091248-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091248-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091248-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091248-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091248-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091248-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091248-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091248-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091248-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091248-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091248-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091248-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091248-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091248-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091248-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091248-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091248-002 | AB | 1 | 87673890dc5c… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-4202-78 | EA - Each | 0378-4202 | 6bf81988-6f9c-4770-9a1d-bb123cd04df7 | 1 | 2014-02-04 |
DailyMed Socrata Ingredients#
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 | MYCOPHENILIC ACID | Archis Pharma LLC | 30cb1078-929b-4c0f-be1d-49ef352dfab9 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | 091248 ANDA091248 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-4202-78 | 00378420278 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4202-78) | 2014-01-08 | 2023-09-30 | No | No | Current |