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NDC 00037-0066-05 Rowasa 4 g/60mL Details
Rowasa 4 g/60mL
Rowasa is a RECTAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meda Pharmaceuticals Inc.. 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: 00037-0066-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mesalamine Rectal
Product Information
| NDC | 00037-0066 |
|---|---|
| Product ID | 0037-0066_28f60c73-ba42-4081-b2d3-c83b3298a92e |
| Associated GPIs | 52500030206420 |
| GCN Sequence Number | 064139 |
| GCN Sequence Number Description | mesalamine w/cleansing wipes ENEMA KIT 4 G/60 ML RECTAL |
| HIC3 | Q3E |
| HIC3 Description | CHRONIC INFLAM. COLON DX, 5-A-SALICYLAT,RECTAL TX |
| GCN | 99847 |
| HICL Sequence Number | 035675 |
| HICL Sequence Number Description | MESALAMINE WITH CLEANSING WIPES |
| Brand/Generic | Brand |
| Proprietary Name | Rowasa |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | mesalamine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | RECTAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | g/60mL |
| Substance Name | MESALAMINE |
| Labeler Name | Meda Pharmaceuticals Inc. |
| Pharmaceutical Class | Aminosalicylate [EPC], Aminosalicylic Acids [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA019618 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00037-0066-05 (00037006605)
| NDC Package Code | 0037-0066-05 |
|---|---|
| Billing NDC | 00037006605 |
| Package | 7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06) |
| Marketing Start Date | 2016-03-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |