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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MYCOPHENOLIC ACID
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MYCOPHENOLATE SODIUM | 360 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WX877SQI1G |
| Rxcui | 485023 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4391-0 | MYCOPHENOLIC ACID | 30 in 1 BOX | TABLET, DELAYED RELEASE | 30 | | 1 |
| 70518-4391-1 | MYCOPHENOLIC ACID | 1 in 1 POUCH | TABLET, DELAYED RELEASE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4391-0 | 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 | Current |
| 70518-4391-1 | 70518439101 | 1 in 1 POUCH | | | | | Historical |