Amantadine Hydrochloride
- Product NDC
- 68999-011
- 11-digit product format
- 689990011
- Labeler code
- 68999
- Product ID
- 68999-011_4651addb-4284-88e1-e063-6294a90a3d13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell Governmental & Specialty RX, LLC.
- Application
- ANDA074028
- Marketing category
- ANDA
- Marketing start
- 1993-06-28
- Substance
- AMANTADINE HYDROCHLORIDE
- Active strength
- 100 mg/10mL
- 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 | 100 mg/10mL |
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 |
|---|
| 68999-011-24 | Amantadine Hydrochloride | 10 in 1 TRAY | SOLUTION | 10 | | 1 |
| 68999-011-24 | Amantadine Hydrochloride | 2 in 1 BOX | SOLUTION | 2 | | 1 |
| 68999-011-59 | Amantadine Hydrochloride | 10 mL in 1 CUP, UNIT-DOSE | 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 |
|---|
| 68999-011-24 | 68999001124 | 2 TRAY in 1 BOX (68999-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68999-011-59) | 2 tray | 2025-12-17 | No | No | Historical |
| 68999-011-59 | 68999001159 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | Historical |