Amantadine Hydrochloride
- Product NDC
- 17856-0093
- 11-digit product format
- 178560093
- Labeler code
- 17856
- Product ID
- 17856-0093_3b3e31b5-ced7-b373-e063-6294a90a16b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMANTADINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA075060
- Marketing category
- ANDA
- Marketing start
- 1998-12-24
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 17856-0093-1 | 2024-05-08 | C162847 | 48780-1 | 9d75b9cf-dfeb-f424-e053-dadaa90a57ce | AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL |
| 17856-0093-3 | 2024-05-08 | C162847 | 48780-1 | 9d75b9cf-dfeb-f424-e053-dadaa90a57ce | AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL |
| 17856-0093-1 | 2022-01-28 | C162847 | 48780-1 | 9d75b9cf-dfeb-f424-e053-dadaa90a57ce | AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL |
| 17856-0093-3 | 2022-01-28 | C162847 | 48780-1 | 9d75b9cf-dfeb-f424-e053-dadaa90a57ce | AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL |
| 17856-0093-1 | 2020-05-20 | C162847 | 48780-1 | 9d75b9cf-dfeb-f424-e053-dadaa90a57ce | AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL |
| 17856-0093-3 | 2020-05-20 | C162847 | 48780-1 | 9d75b9cf-dfeb-f424-e053-dadaa90a57ce | AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL |
| 17856-0093-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dfeb-f424-e053-dadaa90a57ce | AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL |
| 17856-0093-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dfeb-f424-e053-dadaa90a57ce | AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17856-0093-1 | Amantadine Hydrochloride | 72 in 1 BOX, UNIT-DOSE | SOLUTION | 72 | | 6 |
| 17856-0093-1 | Amantadine Hydrochloride | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 6 |
| 17856-0093-3 | Amantadine Hydrochloride | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0093 | AMANTADINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240509_97d6bd4a-31ca-4b33-8353-a536835ef1e1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 17856-0093-1 | 17856009301 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0093-1) > 10 mL in 1 CUP, UNIT-DOSE | | 2020-05-20 | 0000-00-00 | No | No | Current |
| 17856-0093-3 | 17856009303 | 5 mL in 1 CUP, UNIT-DOSE (17856-0093-3) | 5 ml | 2020-05-20 | 0000-00-00 | No | No | Current |