APRISO
- Product NDC
- 43353-884
- 11-digit product format
- 433530884
- Labeler code
- 43353
- Product ID
- 43353-884_08025228-3c71-400b-95ff-80d6aea38f33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA022301
- Marketing category
- NDA
- Marketing start
- 2008-10-31
- Marketing end
- 0000-00-00
- Substance
- MESALAMINE
- Active strength
- 375 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC],Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-884 | APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20171215_faaaa4b7-087e-4c50-820d-561f8f39adc8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-884-79 | 43353088479 | 2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-884-79) | 2014-02-17 | 0000-00-00 | No | No | Current |