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NDC 00378-0396-14 Dimethyl fumarate 120 mg/1 Details
Dimethyl fumarate 120 mg/1
Dimethyl fumarate is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is DIMETHYL FUMARATE.
MedlinePlus Drug Summary
Dimethyl fumarate is used to treat adults with relapsing forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Dimethyl fumarate is in a class of medications called Nrf2 activators. It works by decreasing inflammation and preventing nerve damage that may cause symptoms of multiple sclerosis.
Related Packages: 00378-0396-14Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dimethyl Fumarate
Product Information
| NDC | 00378-0396 |
|---|---|
| Product ID | 0378-0396_7aef99fa-76ed-4750-a283-99cdf7ccc4de |
| Associated GPIs | 62405525006520 |
| GCN Sequence Number | 070786 |
| GCN Sequence Number Description | dimethyl fumarate CAPSULE DR 120 MG ORAL |
| HIC3 | H0E |
| HIC3 Description | AGENTS TO TREAT MULTIPLE SCLEROSIS |
| GCN | 34434 |
| HICL Sequence Number | 040168 |
| HICL Sequence Number Description | DIMETHYL FUMARATE |
| Brand/Generic | Generic |
| Proprietary Name | Dimethyl fumarate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dimethyl fumarate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 120 |
| Active Ingredient Units | mg/1 |
| Substance Name | DIMETHYL FUMARATE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210531 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-0396-14 (00378039614)
| NDC Package Code | 0378-0396-14 |
|---|---|
| Billing NDC | 00378039614 |
| Package | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-0396-14) |
| Marketing Start Date | 2020-08-18 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 6.92871 |
| Pricing Unit | EA |
| Effective Date | 2021-10-20 |
| NDC Description | DIMETHYL FUMARATE DR 120 MG CP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2022-10-12 |