Mesalamine
- Product NDC
- 67877-717
- 11-digit product format
- 678770717
- Labeler code
- 67877
- Product ID
- 67877-717_2eece16c-6316-4dc0-bf4f-25a3f1c08ae5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA214242
- Marketing category
- ANDA
- Marketing start
- 2021-07-16
- Substance
- MESALAMINE
- Active strength
- .375 g/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mesalamine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MESALAMINE | .375 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 825130 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-717-05 | Mesalamine | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 14 |
| 67877-717-12 | Mesalamine | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-717 | MESALAMINE CAPSULE, EXTENDED RELEASE [ASCEND LABORATORIES, LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240704_43f69db3-81ac-4da4-a61f-fbba6299d9c2.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 |
|---|
| 67877-717-05 | 67877071705 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-05) | 2021-07-16 | 0000-00-00 | No | No | Current |
| 67877-717-12 | 67877071712 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-12) | 2021-07-16 | 0000-00-00 | No | No | Current |