Dalfampridine
- Product NDC
- 0591-2533
- 11-digit product format
- 005912533
- Labeler code
- 0591
- Product ID
- 0591-2533_f2d33c82-a69f-4f6a-bd74-2c91efd6cab8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalfampridine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA206836
- Marketing category
- ANDA
- Marketing start
- 2022-05-31
- 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 |
|---|
| 0591-2533-60 | Dalfampridine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2533 | DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20220601_ed826777-b8c4-4d35-aa64-a4c28452baa8.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 |
|---|
| 0591-2533-60 | 00591253360 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2533-60) | 2022-05-31 | 0000-00-00 | No | No | Current |