Mycophenolate Mofetil
- Product NDC
- 69238-1595
- 11-digit product format
- 692381595
- Labeler code
- 69238
- Product ID
- 69238-1595_62350c79-05dc-4568-bd51-489f8221136a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate Mofetil
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA214871
- Marketing category
- ANDA
- Marketing start
- 2021-11-05
- 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 |
|---|
| 69238-1595-2 | Mycophenolate Mofetil | 225 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 225 | | 16 |
| 69238-1595-2 | Mycophenolate Mofetil | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1595 | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC] | 15 | Current NDC, Legacy NDC, 2 package rows | 20231231_27fd9381-8d82-4187-897f-98f41f94e90f.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 |
|---|
| 69238-1595-2 | 69238159502 | 1 BOTTLE, PLASTIC in 1 CARTON (69238-1595-2) / 225 mL in 1 BOTTLE, PLASTIC | 2021-11-05 | 0000-00-00 | No | No | Current |