dalfampridine
- Product NDC
- 0378-0509
- 11-digit product format
- 003780509
- Labeler code
- 0378
- Product ID
- 0378-0509_c1c3e18e-4723-4760-a746-9cbea2b1c812
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dalfampridine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA022250
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-09-10
- Marketing end
- 2022-05-31
- Substance
- DALFAMPRIDINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Potassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0509-91 | 00378050991 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0509-91) | 2018-09-10 | 0000-00-00 | No | No | Current |