CellCept
- Product NDC
- 0004-0261
- 11-digit product format
- 000040261
- Labeler code
- 0004
- Product ID
- 0004-0261_ad799779-cc87-4d12-9836-74375149b84b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolate Mofetil
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Genentech, Inc.
- Application
- NDA050759
- Marketing category
- NDA
- Marketing start
- 1998-10-01
- 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
- CellCept
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MYCOPHENOLATE MOFETIL | 200 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9242ECW6R0, UXH81S8ZVB |
| Rxcui | 199058, 200060, 213394, 311880, 311881, 616435, 616444, 616447 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 04b26d3d-97dc-48db-824b-10b299945382 | Product name | 8 | 20250224 |
| 1aa45098-03f9-4bf8-b28d-2566aa0f7f4b | Product name | 1 | 20250218 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| 267b34ba-ace4-4048-9f21-d3c7ac983fc3 | Product name | 9 | 20210224 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0004-0261-29 | CellCept | 225 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 225 | 50 | |
| 0004-0261-29 | CellCept | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | 50 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0004-0261-29 | ML - Milliliter | 0004-0261 | 3ab4f5c8-1ec1-4743-aba7-bce64fbed13a | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0004-0261 | CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.] | 47 | Current NDC, Legacy NDC, 2 package rows | 20250522_37241e87-4af4-4dc3-a1aa-ea6f20d8dc40.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 616444 | CellCept 200 MG in 1 mL Oral Suspension | PSN | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616447 | CellCept 250 MG Oral Capsule | PSN | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 213394 | CellCept 500 MG Injection | PSN | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616435 | CellCept 500 MG Oral Tablet | PSN | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 311880 | mycophenolate mofetil 200 MG in 1 mL Oral Suspension | PSN | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 199058 | mycophenolate mofetil 250 MG Oral Capsule | PSN | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 311881 | mycophenolate mofetil 500 MG Injection | PSN | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 200060 | mycophenolate mofetil 500 MG Oral Tablet | PSN | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616444 | mycophenolate mofetil 200 MG/ML Oral Suspension [Cellcept] | SBD | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616447 | mycophenolate mofetil 250 MG Oral Capsule [Cellcept] | SBD | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 213394 | mycophenolate mofetil 500 MG Injection [Cellcept] | SBD | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616435 | mycophenolate mofetil 500 MG Oral Tablet [Cellcept] | SBD | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 311880 | mycophenolate mofetil 200 MG/ML Oral Suspension | SCD | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 199058 | mycophenolate mofetil 250 MG Oral Capsule | SCD | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 311881 | mycophenolate mofetil 500 MG Injection | SCD | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 200060 | mycophenolate mofetil 500 MG Oral Tablet | SCD | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616447 | Cellcept (as mycophenolate mofetil) 250 MG Oral Capsule | SY | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616444 | Cellcept 200 MG per 1 ML Oral Suspension | SY | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616444 | Cellcept 200 MG/ML Oral Suspension | SY | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616447 | Cellcept 250 MG Oral Capsule | SY | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 213394 | Cellcept 500 MG Injection | SY | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 616435 | Cellcept 500 MG Oral Tablet | SY | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 311881 | mycophenolate mofetil (as mycophenolate mofetil hydrochloride) 500 MG Injection | SY | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
| 311880 | mycophenolate mofetil 200 MG per 1 ML Oral Suspension | SY | 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 | 50 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0004-0261-29 | 00004026129 | 1 BOTTLE, PLASTIC in 1 CARTON (0004-0261-29) / 225 mL in 1 BOTTLE, PLASTIC | 1998-10-01 | 0000-00-00 | No | No | Current |