MYCOPHENOLIC ACID
- Product NDC
- 67877-427
- 11-digit product format
- 678770427
- Labeler code
- 67877
- Product ID
- 67877-427_27fbf61b-de1e-479a-9d04-6dc1d48f3148
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MYCOPHENOLIC ACID
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA208315
- Marketing category
- ANDA
- Marketing start
- 2021-09-24
- Substance
- MYCOPHENOLATE SODIUM
- Active strength
- 360 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
- MYCOPHENOLIC ACID
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MYCOPHENOLATE SODIUM | 360 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 |
|---|
| 67877-427-05 | MYCOPHENOLIC ACID | 500 in 1 BOTTLE | TABLET, DELAYED RELEASE | 500 | | 16 |
| 67877-427-12 | MYCOPHENOLIC ACID | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 16 |
| 67877-427-33 | MYCOPHENOLIC ACID | 10 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 10 | | 16 |
| 67877-427-38 | MYCOPHENOLIC ACID | 10 in 1 CARTON | TABLET, DELAYED RELEASE | 10 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-427 | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [ASCEND LABORATORIES, LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20230329_2d9975e1-baee-4b0c-83de-8a0a92c5d075.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 |
|---|
| 67877-427-05 | 67877042705 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-05) | | 2021-09-24 | 0000-00-00 | No | No | Current |
| 67877-427-12 | 67877042712 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-12) | | 2021-09-24 | 0000-00-00 | No | No | Current |
| 67877-427-33 | 67877042733 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 67877-427-38 | 67877042738 | 10 BLISTER PACK in 1 CARTON (67877-427-38) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-427-33) | 10 blister pack | 2021-09-24 | 0000-00-00 | No | No | Current |