Mesalamine
- Product NDC
- 42291-489
- 11-digit product format
- 422910489
- Labeler code
- 42291
- Product ID
- 42291-489_485f7bde-a4c9-b05b-e063-6394a90a34cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA213191
- Marketing category
- ANDA
- Marketing start
- 2024-09-25
- Substance
- MESALAMINE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mesalamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MESALAMINE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 833234 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-489-18 | Mesalamine | 180 in 1 BOTTLE | TABLET, DELAYED RELEASE | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-489 | MESALAMINE TABLET, DELAYED RELEASE [AVKARE] | 1 | Current NDC, 1 package rows | 20240927_22f3ee49-ac57-84f5-e063-6394a90aae91.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-489-18 | 42291048918 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-489-18) | 2024-09-25 | No | No | Historical |