Mycophenolate Mofetil
- Product NDC
- 0781-5175
- 11-digit product format
- 007815175
- Labeler code
- 0781
- Product ID
- 0781-5175_8d255117-cfa8-4893-8e2e-945eee7b12c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate Mofetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA065451
- Marketing category
- ANDA
- Marketing start
- 2008-10-15
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 500 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
- Mycophenolate Mofetil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MYCOPHENOLATE MOFETIL | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9242ECW6R0 |
| Rxcui | 199058, 200060 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0781-5175-01 | 2023-08-02 | C162847 | 48780-1 | 0191ceaa-6637-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 |
| 0781-5175-05 | 2023-08-02 | C162847 | 48780-1 | 0191ceaa-6637-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 |
| 0781-5175-10 | 2023-08-02 | C162847 | 48780-1 | 0191ceaa-6637-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 |
| 0781-5175-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6637-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 |
| 0781-5175-05 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6637-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 |
| 0781-5175-10 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6637-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-5175-01 | Mycophenolate Mofetil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 20 |
| 0781-5175-05 | Mycophenolate Mofetil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 20 |
| 0781-5175-10 | Mycophenolate Mofetil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-5175 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [SANDOZ INC] | 18 | Current NDC, Legacy NDC, 3 package rows | 20230803_99b2eb58-8d14-48fc-bbe1-aacb711a783e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0781-5175-01 | 00781517501 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5175-01) | 2008-10-15 | 0000-00-00 | No | No | Current |
| 0781-5175-05 | 00781517505 | 500 TABLET, FILM COATED in 1 BOTTLE (0781-5175-05) | 2008-10-15 | 0000-00-00 | No | No | Current |
| 0781-5175-10 | 00781517510 | 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5175-10) | 2008-10-15 | 0000-00-00 | No | No | Current |