AMPYRA
- Product NDC
- 0259-5010
- 11-digit product format
- 002595010
- Labeler code
- 0259
- Product ID
- 0259-5010_b0f65c2b-ee14-421f-9f24-178e108e38cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalfampridine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Merz Pharmaceuticals, LLC
- Application
- NDA022250
- Marketing category
- NDA
- Marketing start
- 2010-03-01
- 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
- AMPYRA
- 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, 897025 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0259-5010-60 | AMPYRA | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0259-5010 | AMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [MERZ PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20250519_974fb2af-7012-4989-b330-e44a31c9c3e5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0259-5010-60 | 00259501060 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0259-5010-60) | 2010-03-01 | No | No | Historical |