Mycophenolate Mofetil
- Product NDC
- 71288-803
- 11-digit product format
- 712880803
- Labeler code
- 71288
- Product ID
- 71288-803_39b278d4-58de-4a14-a73f-4682305a90f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate Mofetil
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA212130
- Marketing category
- ANDA
- Marketing start
- 2021-01-15
- 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 |
|---|
| 71288-803-20 | Mycophenolate Mofetil | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 15 |
| 71288-803-21 | Mycophenolate Mofetil | 4 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 4 | | 15 |
| 71288-803-91 | Mycophenolate Mofetil | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 1 |
| 71288-803-92 | Mycophenolate Mofetil | 4 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-803 | MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20230908_9650af9b-d36f-4a2f-9647-d0f798933402.zip |
| 71288-803 | MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20240317_b41cca9f-0922-4171-8d1b-8e0d32ae1cc1.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 |
|---|
| 71288-803-20 | 71288080320 | 20 mL in 1 VIAL, SINGLE-DOSE | 20 ml | | | | | Historical |
| 71288-803-21 | 71288080321 | 4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-20) | | 2021-01-15 | 0000-00-00 | No | No | Current |
| 71288-803-91 | 71288080391 | 20 mL in 1 VIAL, SINGLE-DOSE | 20 ml | | | | | Historical |
| 71288-803-92 | 71288080392 | 4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-92) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-91) | | 2021-01-15 | | No | No | Historical |