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NDC 45802-0098-28 Mesalamine 4 g/60mL Details
Mesalamine 4 g/60mL
Mesalamine is a RECTAL ENEMA in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is MESALAMINE.
MedlinePlus Drug Summary
Rectal mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), proctitis (swelling in the rectum), and proctosigmoiditis (swelling in the rectum and sigmoid colon [last section of the colon]). Rectal mesalamine is in a class of medications called anti-inflammatory agents. It works by stopping the body from producing a certain substance that may cause inflammation.
Related Packages: 45802-0098-28Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mesalamine Rectal
Product Information
| NDC | 45802-0098 |
|---|---|
| Product ID | 45802-098_94e1b5cd-8927-4fb6-aeb3-baf0d6a4784c |
| Associated GPIs | 52500030005105 |
| GCN Sequence Number | 004444 |
| GCN Sequence Number Description | mesalamine ENEMA 4 G/60 ML RECTAL |
| HIC3 | Q3E |
| HIC3 Description | CHRONIC INFLAM. COLON DX, 5-A-SALICYLAT,RECTAL TX |
| GCN | 47270 |
| HICL Sequence Number | 001848 |
| HICL Sequence Number Description | MESALAMINE |
| Brand/Generic | Generic |
| Proprietary Name | Mesalamine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Mesalamine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | ENEMA |
| Route | RECTAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | g/60mL |
| Substance Name | MESALAMINE |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| Pharmaceutical Class | Aminosalicylate [EPC], Aminosalicylic Acids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076751 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 45802-0098-28 (45802009828)
| NDC Package Code | 45802-098-28 |
|---|---|
| Billing NDC | 45802009828 |
| Package | 28 BOTTLE in 1 CARTON (45802-098-28) / 60 mL in 1 BOTTLE |
| Marketing Start Date | 2008-02-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |