Mycophenolic Acid
- Product NDC
- 70377-127
- 11-digit product format
- 703770127
- Labeler code
- 70377
- Product ID
- 70377-127_3fff88d0-af7a-defa-0465-70be67431a57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolic Acid
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Biocon Pharma Inc.
- Application
- ANDA217031
- Marketing category
- ANDA
- Marketing start
- 2024-09-30
- 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 |
|---|
| 70377-127-11 | Mycophenolic Acid | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70377-127 | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [BIOCON PHARMA INC.] | 1 | Current NDC, 1 package rows | 20241001_7f8d259a-9880-bb8b-2738-b3c6c1edf152.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70377-127-11 | 70377012711 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-127-11) | 2024-09-30 | No | No | Historical |