Mycophenolate Mofetil
- Product NDC
- 0378-4472
- 11-digit product format
- 003784472
- Labeler code
- 0378
- Product ID
- 0378-4472_c55e1a32-db7a-4605-bab0-972a88414e7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mycophenolate mofetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA065521
- Marketing category
- ANDA
- Marketing start
- 2009-05-04
- Marketing end
- 2026-05-31
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 500 mg/1
- Pharmacologic classes
- Antimetabolite Immunosuppressant [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-4472-01 | Mycophenolate Mofetil | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 20 |
| 0378-4472-05 | Mycophenolate Mofetil | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MYCOPHENOLATE MOFETIL | ACTIVE INGREDIENT | 9242ECW6R0 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| MYCOPHENOLIC ACID | ACTIVE MOIETY | HU9DX48N0T | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4472 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250216_74c3a01e-9451-0f2f-6aab-8348047cb1f5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4472-01 | 00378447201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-01) | 2009-05-04 | 0000-00-00 | No | No | Current |
| 0378-4472-05 | 00378447205 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-05) | 2009-05-04 | 2026-05-31 | No | No | Current |