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NDC 00378-1375-78 Mesalamine 0.375 g/1 Details
Mesalamine 0.375 g/1
Mesalamine is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals 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: 00378-1375-78Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mesalamine
Product Information
| NDC | 00378-1375 |
|---|---|
| Product ID | 0378-1375_74ab5fdd-ccdd-403d-af79-fd34a1cc939f |
| Associated GPIs | 52500030007020 |
| GCN Sequence Number | 064701 |
| GCN Sequence Number Description | mesalamine CAP ER 24H 0.375G ORAL |
| HIC3 | D6F |
| HIC3 Description | DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT |
| GCN | 16159 |
| 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 | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 0.375 |
| Active Ingredient Units | g/1 |
| Substance Name | MESALAMINE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Aminosalicylate [EPC], Aminosalicylic Acids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207271 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-1375-78 (00378137578)
| NDC Package Code | 0378-1375-78 |
|---|---|
| Billing NDC | 00378137578 |
| Package | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78) |
| Marketing Start Date | 2019-11-26 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.72735 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | MESALAMINE ER 0.375 GRAM CAP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
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