Mesalamine
- Product NDC
- 62135-714
- 11-digit product format
- 621350714
- Labeler code
- 62135
- Product ID
- 62135-714_462a53ff-353f-3cdf-e063-6394a90af853
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA217337
- Marketing category
- ANDA
- Marketing start
- 2023-06-03
- Substance
- MESALAMINE
- Active strength
- 1.2 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 | 1.2 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 686429 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-714-12 | Mesalamine | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 3 |
| 62135-714-60 | Mesalamine | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-714 | MESALAMINE TABLET, DELAYED RELEASE [CHARTWELL RX, LLC] | 2 | Current NDC, 2 package rows | 20241025_9703f92d-1d15-4376-8b2b-51502c266012.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-714-12 | 62135071412 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-714-12) | 2023-07-21 | No | No | Current |
| 62135-714-60 | 62135071460 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-714-60) | 2023-07-21 | No | No | Current |