Dalfampridine
- Product NDC
- 16729-292
- 11-digit product format
- 167290292
- Labeler code
- 16729
- Product ID
- 16729-292_40bc3607-8ee1-5a56-e063-6294a90a3b3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalfampridine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA206863
- Marketing category
- ANDA
- Marketing start
- 2018-09-18
- 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 |
|---|
| 16729-292-01 | Dalfampridine | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 8 |
| 16729-292-10 | Dalfampridine | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 8 |
| 16729-292-12 | Dalfampridine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 8 |
| 16729-292-16 | Dalfampridine | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 8 |
| 16729-292-17 | Dalfampridine | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-292 | DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE [ACCORD HEALTHCARE INC.] | 7 | Current NDC, Legacy NDC, 5 package rows | 20240105_354a97e8-35c8-418b-91b2-9e8e066cec65.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 |
|---|
| 16729-292-01 | 16729029201 | 100 in 1 BOTTLE | | | | | Historical |
| 16729-292-10 | 16729029210 | 30 in 1 BOTTLE | | | | | Historical |
| 16729-292-12 | 16729029212 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16729-292-12) | 2018-09-18 | 0000-00-00 | No | No | Current |
| 16729-292-16 | 16729029216 | 500 in 1 BOTTLE | | | | | Historical |
| 16729-292-17 | 16729029217 | 1000 in 1 BOTTLE | | | | | Historical |