Mycophenolate Mofetil
- Product NDC
- 0527-5160
- 11-digit product format
- 005275160
- Labeler code
- 0527
- Product ID
- 0527-5160_6cb7ed46-e457-4e92-8a15-e771e3dca2d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate Mofetil
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA214525
- Marketing category
- ANDA
- Marketing start
- 2021-07-29
- 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 |
|---|
| 0527-5160-82 | Mycophenolate Mofetil | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 11 |
| 0527-5160-82 | Mycophenolate Mofetil | 225 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 225 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-5160 | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [LANNETT COMPANY, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20230930_24c0b94a-c141-44b6-a6f0-ade1669b254c.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 |
|---|
| 0527-5160-82 | 00527516082 | 1 BOTTLE, PLASTIC in 1 CARTON (0527-5160-82) / 225 mL in 1 BOTTLE, PLASTIC | 2021-07-29 | 0000-00-00 | No | No | Current |