DALFAMPRIDINE
- Product NDC
- 65862-863
- 11-digit product format
- 658620863
- Labeler code
- 65862
- Product ID
- 65862-863_8a071f78-8849-495d-ad29-832d5f250a19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DALFAMPRIDINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206811
- Marketing category
- ANDA
- Marketing start
- 2018-06-25
- 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 |
|---|
| 65862-863-01 | DALFAMPRIDINE | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 6 |
| 65862-863-05 | DALFAMPRIDINE | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 6 |
| 65862-863-60 | DALFAMPRIDINE | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-863 | DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240216_43996322-7d83-4420-9e61-4ed37f710fee.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 |
|---|
| 65862-863-01 | 65862086301 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-01) | 2018-06-25 | 0000-00-00 | No | No | Current |
| 65862-863-05 | 65862086305 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-05) | 2018-06-25 | 0000-00-00 | No | No | Current |
| 65862-863-60 | 65862086360 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-60) | 2018-06-25 | 0000-00-00 | No | No | Current |