Dalfampridine
- Product NDC
- 67877-444
- 11-digit product format
- 678770444
- Labeler code
- 67877
- Product ID
- 67877-444_4dbba67c-d169-4c7d-a152-b0e603a4b72b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalfampridine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- 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 |
|---|
| 67877-444-05 | Dalfampridine | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 12 |
| 67877-444-60 | Dalfampridine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 12 |
| 67877-444-90 | Dalfampridine | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-444 | DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE [ASCEND LABORATORIES, LLC] | 12 | Current NDC, Legacy NDC, 3 package rows | 20230202_e10b2d92-2824-4395-8883-6fd52c784aa4.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 |
|---|
| 67877-444-05 | 67877044405 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-05) | 2018-07-31 | 0000-00-00 | No | No | Current |
| 67877-444-60 | 67877044460 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-60) | 2018-07-31 | 0000-00-00 | No | No | Current |
| 67877-444-90 | 67877044490 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-90) | 2018-07-31 | 0000-00-00 | No | No | Current |