Mycophenolate mofetil
- Product NDC
- 70518-2767
- 11-digit product format
- 705182767
- Labeler code
- 70518
- Product ID
- 70518-2767_3e501eaf-87d3-7e12-e063-6294a90a8353
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate mofetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090456
- Marketing category
- ANDA
- Marketing start
- 2020-06-08
- 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 | 200060 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70518-2767-0 | 2023-03-13 | C162847 | 48780-1 | f386c649-a29c-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL CAPSULES and MYCOPHENOLATE MOFETIL TABLETS safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL CAPSULES and MYCOPHENOLATE MOFETIL TABLETS. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-2767-1 | 2023-03-13 | C162847 | 48780-1 | f386c649-a29c-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL CAPSULES and MYCOPHENOLATE MOFETIL TABLETS safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL CAPSULES and MYCOPHENOLATE MOFETIL TABLETS. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-2767-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-a29c-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL CAPSULES and MYCOPHENOLATE MOFETIL TABLETS safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL CAPSULES and MYCOPHENOLATE MOFETIL TABLETS. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-2767-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-a29c-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL CAPSULES and MYCOPHENOLATE MOFETIL TABLETS safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL CAPSULES and MYCOPHENOLATE MOFETIL TABLETS. 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 |
|---|
| 70518-2767-0 | Mycophenolate mofetil | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 7 |
| 70518-2767-1 | Mycophenolate mofetil | 100 in 1 BOX | TABLET, FILM COATED | 100 | | 7 |
| 70518-2767-2 | Mycophenolate mofetil | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2767-0 | 70518276700 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2767-0) | | 2020-06-08 | 0000-00-00 | No | No | Current |
| 70518-2767-1 | 70518276701 | 100 POUCH in 1 BOX (70518-2767-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-2767-2) | 100 pouch | 2021-12-16 | 0000-00-00 | No | No | Current |
| 70518-2767-2 | 70518276702 | 1 in 1 POUCH | | | | | | Historical |