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NDC 59651-0083-14 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 Aurobindo Pharma Limited. The primary component is DIMETHYL FUMARATE.
Product Information
| NDC | 59651-0083 |
|---|---|
| Product ID | 59651-083_b5797a1a-863d-4398-a7c5-6358d3cf85ac |
| Associated GPIs | |
| 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 | Aurobindo Pharma Limited |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210385 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59651-0083-14 (59651008314)
| NDC Package Code | 59651-083-14 |
|---|---|
| Billing NDC | 59651008314 |
| Package | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-083-14) |
| Marketing Start Date | 2022-12-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |