Dalfampridine
- Product NDC
- 63629-9450
- 11-digit product format
- 636299450
- Labeler code
- 63629
- Product ID
- 63629-9450_54a7930d-8690-451e-b3f6-3f27e11ad03e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalfampridine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA206765
- Marketing category
- ANDA
- Marketing start
- 2018-07-31
- 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 |
|---|
| 63629-9450-1 | Dalfampridine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-9450 | DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 1 package rows | 20230317_b9ad68e2-a515-4dba-915d-401c555a8a26.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-9450-1 | 63629945001 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9450-1) | 2022-09-28 | 0000-00-00 | No | No | Current |