Dalfampridine
- Product NDC
- 82249-702
- 11-digit product format
- 822490702
- Labeler code
- 82249
- Product ID
- 82249-702_c40dcc84-b839-44aa-94f2-886fb1c3d75c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalfampridine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CivicaScript LLC
- Application
- ANDA206765
- Marketing category
- ANDA
- Marketing start
- 2025-07-21
- Substance
- DALFAMPRIDINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dalfampridine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DALFAMPRIDINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BH3B64OKL9 |
| Rxcui | 897021 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82249-702-60 | Dalfampridine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82249-702-60 | 82249070260 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82249-702-60) | 2025-07-21 | No | No | Current |