AMANTADINE HYDROCHLORIDE
- Product NDC
- 61037-484
- 11-digit product format
- 610370484
- Labeler code
- 61037
- Product ID
- 61037-484_38fc829b-496d-024d-e063-6294a90a11b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMANTADINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- BAJAJ MEDICAL, LLC
- Application
- ANDA075819
- Marketing category
- ANDA
- Marketing start
- 2025-07-31
- 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
- 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 | 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 |
|---|
| 61037-484-03 | AMANTADINE HYDROCHLORIDE | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 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 |
|---|
| 61037-484-03 | 61037048403 | 473 mL in 1 BOTTLE (61037-484-03) | 473 ml | 2025-07-31 | No | No | Historical |