Mycophenolate mofetil
- Product NDC
- 67877-230
- 11-digit product format
- 678770230
- Labeler code
- 67877
- Product ID
- 67877-230_d57b5ef3-52b0-473c-aa54-3208566e5909
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate mofetil
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA203005
- Marketing category
- ANDA
- Marketing start
- 2014-11-17
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 200 mg/mL
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MYCOPHENOLATE MOFETIL | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9242ECW6R0 |
| Rxcui | 311880 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-230-22 | Mycophenolate mofetil | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 30 |
| 67877-230-22 | Mycophenolate mofetil | 225 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 225 | | 30 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MYCOPHENOLATE MOFETIL | ACTIVE INGREDIENT | 9242ECW6R0 | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
| MYCOPHENOLIC ACID | ACTIVE MOIETY | HU9DX48N0T | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
| FRUIT, UNSPECIFIED | INACTIVE INGREDIENT | C2AIY4ERZC | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-230 | MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] | 27 | Current NDC, Legacy NDC, 2 package rows | 20240216_21ff53b0-b4ba-4473-91e4-76ef41681064.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-230-22 | 67877023022 | 1 BOTTLE, PLASTIC in 1 CARTON (67877-230-22) / 225 mL in 1 BOTTLE, PLASTIC | 2014-11-17 | 0000-00-00 | No | No | Current |