Mesalamine
- Product NDC
- 0093-5907
- 11-digit product format
- 000935907
- Labeler code
- 0093
- Product ID
- 0093-5907_5c416cce-8cdd-4ce2-834d-19783189b85e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA207873
- Marketing category
- ANDA
- Marketing start
- 2019-05-09
- Substance
- MESALAMINE
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 1368954 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-5907-86 | Mesalamine | 180 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 180 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-5907 | MESALAMINE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA, INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20240601_6fd0a906-e1b5-4238-a79b-a195510ddc84.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 |
|---|
| 0093-5907-86 | 00093590786 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86) | 2019-05-09 | 0000-00-00 | No | No | Current |