Dalfampridine
- Product NDC
- 62756-429
- 11-digit product format
- 627560429
- Labeler code
- 62756
- Product ID
- 62756-429_c3c3b8ae-9dac-40fc-8569-b26d6befbf01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalfampridine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA208292
- Marketing category
- ANDA
- Marketing start
- 2019-05-22
- 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 |
|---|
| 62756-429-86 | Dalfampridine | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-429 | DALFAMPRIDINE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20231016_d61e15fa-0334-49a0-ab41-c9a36b726b57.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 |
|---|
| 62756-429-86 | 62756042986 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86) | 2019-05-22 | 0000-00-00 | No | No | Current |