Mycophenolic Acid
- Product NDC
- 82293-013
- 11-digit product format
- 822930013
- Labeler code
- 82293
- Product ID
- 82293-013_1f0154d5-686f-170e-e063-6394a90a67e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolic Acid
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Novugen Pharma (USA) LLC.
- Application
- ANDA216637
- Marketing category
- ANDA
- Marketing start
- 2024-09-01
- Substance
- MYCOPHENOLATE SODIUM
- Active strength
- 360 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 | 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 |
|---|
| 82293-013-10 | Mycophenolic Acid | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82293-013 | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [NOVUGEN PHARMA (USA) LLC.] | 2 | Current NDC, 1 package rows | 20240901_cbc3e916-09e2-4e6e-9e5e-98375f5e6d41.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82293-013-10 | 82293001310 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (82293-013-10) | 2024-09-01 | No | No | Historical |