Amantadine Hydrochloride
- Product NDC
- 71335-2570
- 11-digit product format
- 713352570
- Labeler code
- 71335
- Product ID
- 71335-2570_8518bc0c-9e98-4502-986d-5f75e8658aae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212044
- Marketing category
- ANDA
- Marketing start
- 2020-05-21
- 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
openFDA Listing Details
- Product ID
- 71335-2570_8518bc0c-9e98-4502-986d-5f75e8658aae
- SPL ID
- 8518bc0c-9e98-4502-986d-5f75e8658aae
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Amantadine Hydrochloride
- Generic name
- Amantadine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2020-05-21
- Marketing category
- ANDA
- Application number
- ANDA212044
- Pharmacologic classes
- Influenza A M2 Protein Inhibitor [EPC]; M2 Protein Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| AMANTADINE HYDROCHLORIDE | 100 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | M6Q1EO9TD0 |
| Rxcui | 849389 |
| Spl Set Id | 56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2570-1 | 20 CAPSULE in 1 BOTTLE (71335-2570-1) | 2025-02-05 | No |
| 71335-2570-2 | 30 CAPSULE in 1 BOTTLE (71335-2570-2) | 2025-02-05 | No |
| 71335-2570-3 | 10 CAPSULE in 1 BOTTLE (71335-2570-3) | 2025-02-05 | No |
| 71335-2570-4 | 14 CAPSULE in 1 BOTTLE (71335-2570-4) | 2025-02-05 | No |
| 71335-2570-5 | 60 CAPSULE in 1 BOTTLE (71335-2570-5) | 2025-02-05 | No |
| 71335-2570-6 | 100 CAPSULE in 1 BOTTLE (71335-2570-6) | 2025-02-05 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| M6Q1EO9TD0 | AMANTADINE HYDROCHLORIDE | 665-66-7 | AMANTADINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2570-1 | 71335257001 | 20 CAPSULE in 1 BOTTLE (71335-2570-1) | 20 capsule | 2025-02-05 | No | No | Historical |
| 71335-2570-2 | 71335257002 | 30 CAPSULE in 1 BOTTLE (71335-2570-2) | 30 capsule | 2025-02-05 | No | No | Historical |
| 71335-2570-3 | 71335257003 | 10 CAPSULE in 1 BOTTLE (71335-2570-3) | 10 capsule | 2025-02-05 | No | No | Historical |
| 71335-2570-4 | 71335257004 | 14 CAPSULE in 1 BOTTLE (71335-2570-4) | 14 capsule | 2025-02-05 | No | No | Historical |
| 71335-2570-5 | 71335257005 | 60 CAPSULE in 1 BOTTLE (71335-2570-5) | 60 capsule | 2025-02-05 | No | No | Historical |
| 71335-2570-6 | 71335257006 | 100 CAPSULE in 1 BOTTLE (71335-2570-6) | 100 capsule | 2025-02-05 | No | No | Historical |