Mesalamine
- Product NDC
- 16714-245
- 11-digit product format
- 167140245
- Labeler code
- 16714
- Product ID
- 16714-245_d5210f4f-1604-4319-ad99-b44167e66c00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Northstar Rx LLC.
- Application
- ANDA208953
- Marketing category
- ANDA
- Marketing start
- 2021-08-25
- Substance
- MESALAMINE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 4Q81I59GXC | MESALAMINE | 89-57-6 | MESALAMINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16714-245-30 | 16714024530 | 5 BLISTER PACK in 1 POUCH (16714-245-30) / 6 SUPPOSITORY in 1 BLISTER PACK (16714-245-01) | 5 blister pack | 2021-08-25 | No | No | Historical |