Mycophenolate mofetil
- Product NDC
- 70518-3799
- 11-digit product format
- 705183799
- Labeler code
- 70518
- Product ID
- 70518-3799_3b2912ad-1721-3d82-e063-6394a90ad4fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate mofetil
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090055
- Marketing category
- ANDA
- Marketing start
- 2023-07-18
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 250 mg/1
- 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9242ECW6R0 |
| Rxcui | 199058 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3799-0 | Mycophenolate mofetil | 100 in 1 BOX | CAPSULE | 100 | | 4 |
| 70518-3799-1 | Mycophenolate mofetil | 1 in 1 POUCH | CAPSULE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3799 | MYCOPHENOLATE MOFETIL CAPSULE [REMEDYREPACK INC.] | 3 | Current NDC, 2 package rows | 20241127_77a75d5b-a90d-4ee5-aa8a-6da97d130357.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 |
|---|
| 70518-3799-0 | 70518379900 | 100 POUCH in 1 BOX (70518-3799-0) / 1 CAPSULE in 1 POUCH (70518-3799-1) | 100 pouch | 2023-07-18 | No | No | Historical |
| 70518-3799-1 | 70518379901 | 1 in 1 POUCH | | | | | Historical |