Mycophenolic Acid
- Product NDC
- 60505-2965
- 11-digit product format
- 605052965
- Labeler code
- 60505
- Product ID
- 60505-2965_fa09fa75-fabc-fac1-8b3e-772bcf55939a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolic Acid
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Apotex Corp
- Application
- ANDA091558
- Marketing category
- ANDA
- Marketing start
- 2012-08-21
- Substance
- MYCOPHENOLATE SODIUM
- Active strength
- 180 mg/1
- Pharmacologic classes
- Antimetabolite Immunosuppressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mycophenolic Acid
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MYCOPHENOLATE SODIUM | 180 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | WX877SQI1G |
| Rxcui | 485020, 485023 |
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 |
|---|---|---|---|---|---|---|
| 60505-2965-0 | Mycophenolic Acid | 10 in 1 CARTON | TABLET, DELAYED RELEASE | 10 | 25 | |
| 60505-2965-0 | Mycophenolic Acid | 10 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 10 | 25 | |
| 60505-2965-1 | Mycophenolic Acid | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | 25 | |
| 60505-2965-3 | Mycophenolic Acid | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | 25 | |
| 60505-2965-5 | Mycophenolic Acid | 500 in 1 BOTTLE | TABLET, DELAYED RELEASE | 500 | 25 | |
| 60505-2965-6 | Mycophenolic Acid | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | 25 | |
| 60505-2965-7 | Mycophenolic Acid | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | 25 | |
| 60505-2965-8 | Mycophenolic Acid | 1000 in 1 BOTTLE | TABLET, DELAYED RELEASE | 1000 | 25 | |
| 60505-2965-9 | Mycophenolic Acid | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | 25 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-2965-7 | EA - Each | 60505-2965 | 89b5e6c8-f17d-4520-8baa-29f7fe9c406b | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60505-2965 | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP] | 24 | Current NDC, Legacy NDC, 9 package rows | 20250411_c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | PSN | c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0 | 25 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | PSN | c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0 | 25 |
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | SCD | c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0 | 25 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | SCD | c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0 | 25 |
| 485020 | mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet | SY | c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0 | 25 |
| 485023 | mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet | SY | c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0 | 25 |
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | PSN | 3a0a6ef4-fb2c-47be-82d7-d2675059c45b | 13 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | PSN | 3a0a6ef4-fb2c-47be-82d7-d2675059c45b | 13 |
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | SCD | 3a0a6ef4-fb2c-47be-82d7-d2675059c45b | 13 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | SCD | 3a0a6ef4-fb2c-47be-82d7-d2675059c45b | 13 |
| 485020 | mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet | SY | 3a0a6ef4-fb2c-47be-82d7-d2675059c45b | 13 |
| 485023 | mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet | SY | 3a0a6ef4-fb2c-47be-82d7-d2675059c45b | 13 |
| 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 |
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | PSN | 93763b39-ba21-449b-bdc5-254ba57154e4 | 5 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | PSN | 93763b39-ba21-449b-bdc5-254ba57154e4 | 5 |
| 485020 | mycophenolic acid 180 MG Delayed Release Oral Tablet | SCD | 93763b39-ba21-449b-bdc5-254ba57154e4 | 5 |
| 485023 | mycophenolic acid 360 MG Delayed Release Oral Tablet | SCD | 93763b39-ba21-449b-bdc5-254ba57154e4 | 5 |
| 485020 | mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral Tablet | SY | 93763b39-ba21-449b-bdc5-254ba57154e4 | 5 |
| 485023 | mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral Tablet | SY | 93763b39-ba21-449b-bdc5-254ba57154e4 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60505-2965-0 | 60505296500 | 10 in 1 CARTON | Historical | ||||
| 60505-2965-1 | 60505296501 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-1) | 2012-08-21 | 2021-06-30 | No | No | Current |
| 60505-2965-3 | 60505296503 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-3) | 2012-08-21 | 2021-06-30 | No | No | Current |
| 60505-2965-5 | 60505296505 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-5) | 2012-08-21 | 2021-06-30 | No | No | Current |
| 60505-2965-6 | 60505296506 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-6) | 2012-08-21 | 2021-06-30 | No | No | Current |
| 60505-2965-7 | 60505296507 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-7) | 2012-08-21 | 0000-00-00 | No | No | Current |
| 60505-2965-8 | 60505296508 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-8) | 2012-08-21 | 2021-06-30 | No | No | Current |
| 60505-2965-9 | 60505296509 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (60505-2965-9) | 2012-08-21 | 2021-06-30 | No | No | Current |