AMANTADINE HYDROCHLORIDE
- Product NDC
- 55154-9444
- 11-digit product format
- 551549444
- Labeler code
- 55154
- Product ID
- 55154-9444_cd832f95-6827-4dfb-81e7-1c2fa406cb70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMANTADINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA074509
- Marketing category
- ANDA
- Marketing start
- 1995-07-17
- 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 519d6abc-639d-2962-cced-abbf8b16aad4 | Product name | 7 | 20250401 |
| 82f46845-b4c7-48da-a389-ba5721b956c9 | Product name | 2 | 20250325 |
| d2c037c0-5ebf-d224-252f-2549922c21c7 | Product name | 7 | 20240208 |
| b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721 | Product name | 2 | 20220224 |
| 14e11aaf-885f-472f-a02a-c6a3f28df907 | Product name | 1 | 20180515 |
| 82f46845-b4c7-48da-a389-ba5721b956c9 | Product name | 1 | 20171103 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55154-9444-5 | AMANTADINE HYDROCHLORIDE | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 10 | |
| 55154-9444-5 | AMANTADINE HYDROCHLORIDE | 5 in 1 BAG | SOLUTION | 5 | 10 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | ACTIVE INGREDIENT | M6Q1EO9TD0 | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] | 2 | |
| AMANTADINE | ACTIVE MOIETY | BF4C9Z1J53 | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55154-9444 | AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH 107, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240410_5989098d-2855-4b5f-9a06-64a83656c078.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 849385 | amantadine HCl 50 MG in 5 mL Oral Solution | PSN | 5989098d-2855-4b5f-9a06-64a83656c078 | 10 |
| 849385 | amantadine hydrochloride 10 MG/ML Oral Solution | SCD | 5989098d-2855-4b5f-9a06-64a83656c078 | 10 |
| 849385 | amantadine hydrochloride 100 MG per 10 ML Oral Solution | SY | 5989098d-2855-4b5f-9a06-64a83656c078 | 10 |
| 849385 | amantadine hydrochloride 50 MG per 5 ML Oral Solution | SY | 5989098d-2855-4b5f-9a06-64a83656c078 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55154-9444-5 | 55154944405 | 5 CUP, UNIT-DOSE in 1 BAG (55154-9444-5) / 10 mL in 1 CUP, UNIT-DOSE | 1995-07-17 | 0000-00-00 | No | No | Current |