Mycophenolate Mofetil
- Product NDC
- 51079-721
- 11-digit product format
- 510790721
- Labeler code
- 51079
- Product ID
- 51079-721_d43aef74-43df-6315-e053-2a95a90ab4c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mycophenolate mofetil
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA065520
- Marketing category
- ANDA
- Marketing start
- 2009-06-01
- Marketing end
- 2030-01-31
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 250 mg/1
- Pharmacologic classes
- Antimetabolite Immunosuppressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
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 INSTITUTIONAL INC.] | 3 | |
| MYCOPHENOLIC ACID | ACTIVE MOIETY | HU9DX48N0T | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-721 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 13 | Legacy NDC | 20250327_52907069-4a29-4351-a830-a9ee86b5ff7c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51079-721-20 | 51079072120 | 100 BLISTER PACK in 1 CARTON (51079-721-20) > 1 CAPSULE in 1 BLISTER PACK (51079-721-01) | 100 blister pack | 2009-06-01 | 0000-00-00 | No | No | Current |