Amantadine Hydrochloride
- Product NDC
- 64380-862
- 11-digit product format
- 643800862
- Labeler code
- 64380
- Product ID
- 64380-862_cd49441d-853e-4400-90bb-8e9e81d96b9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA211354
- Marketing category
- ANDA
- Marketing start
- 2022-12-01
- 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 |
|---|
| 64380-862-06 | Amantadine Hydrochloride | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | | 7 |
| 64380-862-07 | Amantadine Hydrochloride | 500 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-862 | AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230718_20dad861-6ad1-4660-b315-8af57b294175.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 |
|---|
| 64380-862-06 | 64380086206 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-06) | 2022-12-01 | 0000-00-00 | No | No | Current |
| 64380-862-07 | 64380086207 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-07) | 2022-12-01 | 0000-00-00 | No | No | Current |