Mycophenolate Mofetil
- Product NDC
- 59651-638
- 11-digit product format
- 596510638
- Labeler code
- 59651
- Product ID
- 59651-638_abdd39b5-dac9-4e5c-9722-17473947909d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate Mofetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA217937
- Marketing category
- ANDA
- Marketing start
- 2024-02-20
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9242ECW6R0 |
| Rxcui | 200060 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-638-01 | Mycophenolate Mofetil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 59651-638-05 | Mycophenolate Mofetil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-638 | MYCOPHENOLATE MOFETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 2 package rows | 20240228_8faf357b-99a1-440b-8eac-8545cb19a69c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-638-01 | 59651063801 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-638-01) | 2024-02-20 | No | No | Historical |
| 59651-638-05 | 59651063805 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-638-05) | 2024-02-20 | No | No | Historical |