mycophenolate mofetil
- Product NDC
- 16729-019
- 11-digit product format
- 167290019
- Labeler code
- 16729
- Product ID
- 16729-019_50ae55f7-2f85-5d74-e063-6394a90acdb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mycophenolate mofetil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA065416
- Marketing category
- ANDA
- Marketing start
- 2009-05-04
- 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 |
|---|
| 16729-019-01 | mycophenolate mofetil | 100 in 1 BOTTLE | TABLET | 100 | | 14 |
| 16729-019-16 | mycophenolate mofetil | 500 in 1 BOTTLE | TABLET | 500 | | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-019 | MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ACCORD HEALTHCARE INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240106_741e079a-646b-47ec-84ac-8e12574c2aaf.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 |
|---|
| 16729-019-01 | 16729001901 | 100 TABLET in 1 BOTTLE (16729-019-01) | 100 tablet | 2009-05-04 | 0000-00-00 | No | No | Current |
| 16729-019-16 | 16729001916 | 500 TABLET in 1 BOTTLE (16729-019-16) | 500 tablet | 2009-05-04 | 0000-00-00 | No | No | Current |