Amantadine
- Product NDC
- 50268-036
- 11-digit product format
- 502680036
- Labeler code
- 50268
- Product ID
- 50268-036_48c949ef-d92b-abba-e063-6394a90a2d2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA075060
- Marketing category
- ANDA
- Marketing start
- 2026-01-19
- Substance
- AMANTADINE HYDROCHLORIDE
- Active strength
- 50 mg/5mL
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMANTADINE HYDROCHLORIDE | 50 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M6Q1EO9TD0 |
| Rxcui | 849385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-036-11 | Amantadine | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 1 |
| 50268-036-14 | Amantadine | 40 in 1 CASE | SOLUTION | 40 | | 1 |
| 50268-036-14 | Amantadine | 10 in 1 TRAY | SOLUTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50268-036-11 | 50268003611 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | Historical |
| 50268-036-14 | 50268003614 | 40 TRAY in 1 CASE (50268-036-14) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (50268-036-11) | 40 tray | 2026-01-19 | No | No | Historical |