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NDC 71558-0590-28 ARIKAYCE 590 mg/8.4mL Details
ARIKAYCE 590 mg/8.4mL
ARIKAYCE is a RESPIRATORY (INHALATION) SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Insmed Incorporated. The primary component is AMIKACIN.
Product Information
| NDC | 71558-0590 |
|---|---|
| Product ID | 71558-590_6234782d-94c1-428b-b34b-c5d0db96d9d7 |
| Associated GPIs | 07000010121830 |
| GCN Sequence Number | 079020 |
| GCN Sequence Number Description | amikacin liposomal/neb.accessr VIAL-NEB 590 MG/8.4 INHALATION |
| HIC3 | W1F |
| HIC3 Description | AMINOGLYCOSIDE ANTIBIOTICS |
| GCN | 45435 |
| HICL Sequence Number | 045298 |
| HICL Sequence Number Description | AMIKACIN SULFATE LIPOSOMAL WITH NEBULIZER ACCESSORIES |
| Brand/Generic | Brand |
| Proprietary Name | ARIKAYCE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Amikacin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 590 |
| Active Ingredient Units | mg/8.4mL |
| Substance Name | AMIKACIN |
| Labeler Name | Insmed Incorporated |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA207356 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71558-0590-28 (71558059028)
| NDC Package Code | 71558-590-28 |
|---|---|
| Billing NDC | 71558059028 |
| Package | 28 VIAL in 1 CARTON (71558-590-28) / 8.4 mL in 1 VIAL |
| Marketing Start Date | 2018-10-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |