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NDC 70518-3239-00 MESALAMINE 400 mg/1 Details
MESALAMINE 400 mg/1
MESALAMINE is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is MESALAMINE.
MedlinePlus Drug Summary
Mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) and also to maintain improvement of ulcerative colitis symptoms. 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: 70518-3239-00Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mesalamine
Product Information
| NDC | 70518-3239 |
|---|---|
| Product ID | 70518-3239_f77d8e26-8aa9-8183-e053-6294a90a0d88 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | MESALAMINE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | MESALAMINE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/1 |
| Substance Name | MESALAMINE |
| Labeler Name | REMEDYREPACK INC. |
| Pharmaceutical Class | Aminosalicylate [EPC], Aminosalicylic Acids [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA204412 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70518-3239-00 (70518323900)
| NDC Package Code | 70518-3239-0 |
|---|---|
| Billing NDC | 70518323900 |
| Package | 30 POUCH in 1 BOX (70518-3239-0) / 1 CAPSULE, DELAYED RELEASE in 1 POUCH (70518-3239-1) |
| Marketing Start Date | 2021-10-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |