dalfampridine
- Product NDC
- 0378-4504
- 11-digit product format
- 003784504
- Labeler code
- 0378
- Product ID
- 0378-4504_0f8d5e1e-9f72-459f-9fbf-fd38c7ece962
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dalfampridine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206858
- Marketing category
- ANDA
- Marketing start
- 2022-05-31
- Marketing end
- 0000-00-00
- Substance
- DALFAMPRIDINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 0378-4504-05 | 00378450405 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4504-05) | 2022-05-31 | 0000-00-00 | No | No | Current |
| 0378-4504-80 | 00378450480 | 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4504-80) | 2022-05-31 | 0000-00-00 | No | No | Current |
| 0378-4504-91 | 00378450491 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4504-91) | 2022-05-31 | 0000-00-00 | No | No | Current |