MYCOPHENOLATE MOFETIL
- Product NDC
- 59651-646
- 11-digit product format
- 596510646
- Labeler code
- 59651
- Product ID
- 59651-646_83531645-459d-4746-bc46-2d32928e9417
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mycophenolate mofetil
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA218227
- Marketing category
- ANDA
- Marketing start
- 2024-09-26
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 200 mg/mL
- 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 | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9242ECW6R0 |
| Rxcui | 311880 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-646-26 | MYCOPHENOLATE MOFETIL | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 2 |
| 59651-646-26 | MYCOPHENOLATE MOFETIL | 225 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 225 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-646 | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 2 package rows | 20241008_20fa7709-a203-481f-aaf4-e98fab1acd0d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-646-26 | 59651064626 | 1 BOTTLE in 1 CARTON (59651-646-26) / 225 mL in 1 BOTTLE | 1 bottle | 2024-09-26 | No | No | Historical |