Amantadine HCL
- Product NDC
- 72189-535
- 11-digit product format
- 721890535
- Labeler code
- 72189
- Product ID
- 72189-535_12894d87-0c1f-831b-e063-6294a90af11d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine HCL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA209035
- Marketing category
- ANDA
- Marketing start
- 2024-02-23
- 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 HCL
- 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 | 849395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-535-30 | Amantadine HCL | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 72189-535-90 | Amantadine HCL | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-535 | AMANTADINE HCL TABLET [DIRECT_RX] | 4 | Current NDC, 2 package rows | 20240302_1211ebf4-3169-20ca-e063-6294a90aee4d.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 |
|---|
| 72189-535-30 | 72189053530 | 30 TABLET in 1 BOTTLE (72189-535-30) | 30 tablet | 2024-02-23 | No | No | Current |
| 72189-535-90 | 72189053590 | 90 TABLET in 1 BOTTLE (72189-535-90) | 90 tablet | 2024-02-23 | No | No | Current |