Mycophenolate Mofetil
- Product NDC
- 67877-225
- 11-digit product format
- 678770225
- Labeler code
- 67877
- Product ID
- 67877-225_f8b5a092-55fd-4e91-aa56-98fe69f1c091
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate Mofetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA091249
- Marketing category
- ANDA
- Marketing start
- 2011-11-28
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 500 mg/1
- Pharmacologic classes
- Antimetabolite Immunosuppressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9242ECW6R0 |
| Rxcui | 199058, 200060 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-225-01 | Mycophenolate Mofetil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 36 |
| 67877-225-05 | Mycophenolate Mofetil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 36 |
| 67877-225-38 | Mycophenolate Mofetil | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 36 |
| 67877-225-38 | Mycophenolate Mofetil | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 36 |
| 67877-225-84 | Mycophenolate Mofetil | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 36 |
| 67877-225-84 | Mycophenolate Mofetil | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 36 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MYCOPHENOLATE MOFETIL | ACTIVE INGREDIENT | 9242ECW6R0 | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| MYCOPHENOLIC ACID | ACTIVE MOIETY | HU9DX48N0T | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-225 | MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] | 33 | Current NDC, Legacy NDC, 6 package rows | 20240823_9f84ea84-2d8b-4d91-a33f-7dfb5df937dc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-225-01 | 67877022501 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-225-01) | | 2011-11-28 | 0000-00-00 | No | No | Current |
| 67877-225-05 | 67877022505 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-225-05) | | 2011-11-28 | 0000-00-00 | No | No | Current |
| 67877-225-38 | 67877022538 | 10 BLISTER PACK in 1 CARTON (67877-225-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2011-11-28 | 0000-00-00 | No | No | Current |
| 67877-225-84 | 67877022584 | 3 BLISTER PACK in 1 CARTON (67877-225-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2011-11-28 | 0000-00-00 | No | No | Current |