mycophenolic acid
- Product NDC
- 68254-5001
- 11-digit product format
- 682545001
- Labeler code
- 68254
- Product ID
- 68254-5001_47ef003d-aa2a-4b8e-9ab4-bba4cde21f09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mycophenolic acid
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- CONCORD BIOTECH LIMITED
- Application
- ANDA211173
- Marketing category
- ANDA
- Marketing start
- 2019-12-13
- Substance
- MYCOPHENOLATE SODIUM
- Active strength
- 180 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
- mycophenolic acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MYCOPHENOLATE SODIUM | 180 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WX877SQI1G |
| Rxcui | 485020, 485023 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68254-5001-1 | mycophenolic acid | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 10 |
| 68254-5001-2 | mycophenolic acid | 1000 in 1 BOTTLE | TABLET, DELAYED RELEASE | 1000 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68254-5001 | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [CONCORD BIOTECH LIMITED] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240514_a374549e-8afd-48fe-ae3f-368984689a2a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68254-5001-1 | 68254500101 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5001-1) | 2019-12-13 | 0000-00-00 | No | No | Current |
| 68254-5001-2 | 68254500102 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5001-2) | 2019-12-13 | 0000-00-00 | No | No | Current |