Mycophenolate Mofetil
- Product NDC
- 0054-0163
- 11-digit product format
- 000540163
- Labeler code
- 0054
- Product ID
- 0054-0163_d938a1b7-eed3-4e23-bfef-f88c443d9267
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate Mofetil
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA065410
- Marketing category
- ANDA
- Marketing start
- 2008-07-29
- Substance
- MYCOPHENOLATE MOFETIL
- Active strength
- 250 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 | 250 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 |
|---|
| 0054-0163-25 | Mycophenolate Mofetil | 100 in 1 BOTTLE | CAPSULE | 100 | | 21 |
| 0054-0163-29 | Mycophenolate Mofetil | 500 in 1 BOTTLE | CAPSULE | 500 | | 21 |
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 [ROXANE LABORATORIES, INC] | 10 | |
| MYCOPHENOLIC ACID | ACTIVE MOIETY | HU9DX48N0T | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] | 10 | |
| MYCOPHENOLATE MOFETIL | ACTIVE INGREDIENT | 9242ECW6R0 | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| MYCOPHENOLIC ACID | ACTIVE MOIETY | HU9DX48N0T | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0163 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [HIKMA PHARMACEUTICALS USA INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20220924_e94895d9-f040-4a75-9f04-9814238b8f3c.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 |
|---|
| 0054-0163-25 | 00054016325 | 100 CAPSULE in 1 BOTTLE (0054-0163-25) | 100 capsule | 2008-07-29 | 0000-00-00 | No | No | Current |
| 0054-0163-29 | 00054016329 | 500 CAPSULE in 1 BOTTLE (0054-0163-29) | 500 capsule | 2008-07-29 | 0000-00-00 | No | No | Current |