mesalamine
- Product NDC
- 68682-113
- 11-digit product format
- 686820113
- Labeler code
- 68682
- Product ID
- 68682-113_0ce2b1db-0b45-4548-e063-6294a90a84f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA022301
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-07-19
- Substance
- MESALAMINE
- Active strength
- 375 mg/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 mg/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 |
|---|
| 68682-113-20 | mesalamine | 1 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 1 | | 9 |
| 68682-113-20 | mesalamine | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-113 | MESALAMINE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS] | 9 | Current NDC, Legacy NDC, 2 package rows | 20231220_cfe4800f-868f-46fd-8b9a-977a91ae5fbe.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 |
|---|
| 68682-113-20 | 68682011320 | 1 BOTTLE in 1 CARTON (68682-113-20) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2018-07-19 | 0000-00-00 | No | No | Current |