amantadine hydrochloride
- Product NDC
- 42806-716
- 11-digit product format
- 428060716
- Labeler code
- 42806
- Product ID
- 42806-716_1497ce1d-a997-4828-a08d-3f93653a88d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amantadine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- EPIC PHARMA LLC
- Application
- ANDA214580
- Marketing category
- ANDA
- Marketing start
- 2021-06-17
- Substance
- AMANTADINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- amantadine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMANTADINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M6Q1EO9TD0 |
| Rxcui | 849389 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-716-05 | amantadine hydrochloride | 500 in 1 BOTTLE | CAPSULE | 500 | | 8 |
| 42806-716-11 | amantadine hydrochloride | 10 in 1 BOTTLE | CAPSULE | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-716 | AMANTADINE HYDROCHLORIDE CAPSULE [EPIC PHARMA LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250510_0f70c79a-92a4-4a38-bbdd-900adc4c2e93.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42806-716-05 | 42806071605 | 500 CAPSULE in 1 BOTTLE (42806-716-05) | 500 capsule | 2021-06-17 | 0000-00-00 | No | No | Current |
| 42806-716-10 | 42806071610 | 10 CAPSULE in 1 BOTTLE (42806-716-10) | 10 capsule | 2022-12-30 | 0000-00-00 | No | No | Current |
| 42806-716-11 | 42806071611 | 10 CAPSULE in 1 BOTTLE (42806-716-11) | 10 capsule | 2021-06-17 | | No | No | Historical |