Mycophenolate Mofetil
- Product NDC
- 67457-386
- 11-digit product format
- 674570386
- Labeler code
- 67457
- Product ID
- 67457-386_4c643876-2577-4197-ac9b-81bab65d1362
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate Mofetil
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA203859
- Marketing category
- ANDA
- Marketing start
- 2021-01-26
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 500 mg/20mL
- 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/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9242ECW6R0 |
| Rxcui | 311881 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-386-00 | Mycophenolate Mofetil | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 5 |
| 67457-386-81 | Mycophenolate Mofetil | 4 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 4 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-386 | MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230105_da02b428-42a4-4007-b0b7-695f2db010f2.zip |
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 |
|---|
| 67457-386-00 | 67457038600 | 20 mL in 1 VIAL | 20 ml | | | | | Historical |
| 67457-386-81 | 67457038681 | 4 VIAL in 1 CARTON (67457-386-81) / 20 mL in 1 VIAL (67457-386-00) | 4 vial | 2021-01-26 | 0000-00-00 | No | No | Current |