AMANTADINE HYDROCHLORIDE
- Product NDC
- 71765-009
- 11-digit product format
- 717650009
- Labeler code
- 71765
- Product ID
- 71765-009_4df85675-4d84-2a33-e063-6394a90a9ddc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zhejiang Jutai Pharmaceutical Co., Ltd.
- Application
- ANDA218598
- Marketing category
- ANDA
- Marketing start
- 2024-09-26
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AMANTADINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
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 |
|---|
| 71765-009-01 | AMANTADINE HYDROCHLORIDE | 2 in 1 BOX | TABLET | 2 | | 4 |
| 71765-009-01 | AMANTADINE HYDROCHLORIDE | 12 in 1 BLISTER PACK | TABLET | 12 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71765-009-01 | 71765000901 | 2 BLISTER PACK in 1 BOX (71765-009-01) / 12 TABLET in 1 BLISTER PACK | 2 blister pack | 2024-09-26 | No | No | Historical |