Mesalamine
- Product NDC
- 62559-420
- 11-digit product format
- 625590420
- Labeler code
- 62559
- Product ID
- 62559-420_def117ab-832b-4d92-b005-cf2f53d52899
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- ENEMA
- Route
- RECTAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA019618
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-05-13
- Substance
- MESALAMINE
- Active strength
- 4 g/60mL
- 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 | 4 g/60mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 238151 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-420-07 | Mesalamine | 7 in 1 BOX | ENEMA | 7 | | 9 |
| 62559-420-11 | Mesalamine | 60 mL in 1 BOTTLE | ENEMA | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-420 | MESALAMINE ENEMA [ANI PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240217_3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac.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 |
|---|
| 62559-420-07 | 62559042007 | 7 BOTTLE in 1 BOX (62559-420-07) / 60 mL in 1 BOTTLE (62559-420-11) | 7 bottle | 2016-05-13 | 0000-00-00 | No | No | Current |
| 62559-420-11 | 62559042011 | 60 mL in 1 BOTTLE | 60 ml | | | | | Historical |