Mesalamine
- Product NDC
- 45802-098
- 11-digit product format
- 458020098
- Labeler code
- 45802
- Product ID
- 45802-098_f416ded9-2018-4422-8cff-c6fc563a3772
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- ENEMA
- Route
- RECTAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA076751
- Marketing category
- ANDA
- Marketing start
- 2007-10-11
- 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#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-098 | MESALAMINE KIT [BRYANT RANCH PREPACK] | 106 | Current NDC, Legacy NDC | 20241109_1e561474-6169-410e-b83d-7e96d375831d.zip |
| 45802-098 | MESALAMINE KIT [BRYANT RANCH PREPACK] | 106 | Current NDC, Legacy NDC | 20241109_9756d07b-2939-460f-94d3-e338c28cb993.zip |
| 45802-098 | MESALAMINE ENEMA [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 14 | Current NDC, Legacy NDC, 5 package rows | 20250224_a4ddf68d-1502-4242-89aa-c96436bdcbf6.zip |
| 45802-098 | MESALAMINE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 14 | Current NDC, Legacy NDC | 20241017_d50f2c37-5675-49f3-bdd4-3b16d333ed40.zip |
| 45802-098 | MESALAMINE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 8 | Current NDC, Legacy NDC | 20241017_b2a5b110-7537-4ffc-bf0a-f0fe13379c9d.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 |
|---|
| 45802-098-28 | 45802009828 | 28 BOTTLE in 1 CARTON (45802-098-28) / 60 mL in 1 BOTTLE | 28 bottle | 2008-02-12 | 0000-00-00 | No | No | Current |
| 45802-098-46 | 45802009846 | 60 mL in 1 BOTTLE (45802-098-46) | 60 ml | 2007-10-11 | 0000-00-00 | No | No | Current |
| 45802-098-51 | 45802009851 | 7 BOTTLE in 1 CARTON (45802-098-51) / 60 mL in 1 BOTTLE | 7 bottle | 2007-10-11 | 0000-00-00 | No | No | Current |