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NDC 42571-0275-05 DALFAMPRIDINE 10 mg/1 Details
DALFAMPRIDINE 10 mg/1
DALFAMPRIDINE is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Micro Labs Limited. The primary component is DALFAMPRIDINE.
MedlinePlus Drug Summary
Dalfampridine is used to improve walking in people who have multiple sclerosis (MS; a disease in which the nerves do not function properly and may cause weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Dalfampridine may be used alone or with other medications that control the symptoms of MS. Dalfampridine is in a class of medications called potassium channel blockers. It works by strengthening the signals sent by the brain through nerves that have been damaged by MS.
Related Packages: 42571-0275-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dalfampridine
Product Information
| NDC | 42571-0275 |
|---|---|
| Product ID | 42571-275_ee82b88c-e152-0978-e053-2a95a90ab5f1 |
| Associated GPIs | 62406030007420 |
| GCN Sequence Number | 066066 |
| GCN Sequence Number Description | dalfampridine TAB ER 12H 10 MG ORAL |
| HIC3 | H0F |
| HIC3 Description | AGTS TX NEUROMUSC TRANSMISSION DIS,POT-CHAN BLKR |
| GCN | 28246 |
| HICL Sequence Number | 013907 |
| HICL Sequence Number Description | DALFAMPRIDINE |
| Brand/Generic | Generic |
| Proprietary Name | DALFAMPRIDINE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DALFAMPRIDINE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | DALFAMPRIDINE |
| Labeler Name | Micro Labs Limited |
| Pharmaceutical Class | Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210158 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42571-0275-05 (42571027505)
| NDC Package Code | 42571-275-05 |
|---|---|
| Billing NDC | 42571027505 |
| Package | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05) |
| Marketing Start Date | 2019-03-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |