MYCOPHENOLIC ACID
- Product NDC
- 70518-4391
- 11-digit product format
- 705184391
- Labeler code
- 70518
- Product ID
- 70518-4391_39f7886b-ec90-a8b4-e063-6394a90a9065
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MYCOPHENOLIC ACID
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208315
- Marketing category
- ANDA
- Marketing start
- 2025-07-15
- Substance
- MYCOPHENOLATE SODIUM
- Active strength
- 360 mg/1
- Pharmacologic classes
- Antimetabolite Immunosuppressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| WX877SQI1G | MYCOPHENOLATE SODIUM | 37415-62-6 | MYCOPHENOLATE SODIUM |
| HU9DX48N0T | MYCOPHENOLIC ACID | 24280-93-1 | MYCOPHENOLIC ACID |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4391-0 | 70518439100 | 30 POUCH in 1 BOX (70518-4391-0) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-4391-1) | 30 pouch | 2025-07-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| MYCOPHENOLIC ACID | REMEDYREPACK INC. | 2025-07-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |