Amantadine Hydrochloride
- Product NDC
- 0615-8263
- 11-digit product format
- 006158263
- Labeler code
- 0615
- Product ID
- 0615-8263_056d9ef2-8e38-40eb-8d3a-0d753e018030
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA209171
- Marketing category
- ANDA
- Marketing start
- 2017-01-01
- 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 |
|---|
| 0615-8263-39 | Amantadine Hydrochloride | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8263 | AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240806_b54064bc-b3e1-4d83-be40-fcaddd2e99d0.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 |
|---|
| 0615-8263-39 | 00615826339 | 30 CAPSULE in 1 BLISTER PACK (0615-8263-39) | 30 capsule | 2019-01-10 | 0000-00-00 | No | No | Current |