amantadine hydrochloride
- Product NDC
- 67046-1508
- 11-digit product format
- 670461508
- Labeler code
- 67046
- Product ID
- 67046-1508_2cb6e7e3-9e71-6a9c-e063-6394a90ab7c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amantadine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA208278
- Marketing category
- ANDA
- Marketing start
- 2025-01-27
- 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 |
|---|
| 67046-1508-3 | amantadine hydrochloride | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1508 | AMANTADINE HYDROCHLORIDE CAPSULE [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250129_2cb6e83d-e635-b150-e063-6294a90ad61d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1508-3 | 67046150803 | 30 CAPSULE in 1 BLISTER PACK (67046-1508-3) | 30 capsule | 2025-01-27 | No | No | Current |