ARIKAYCE
- Product NDC
- 71558-590
- 11-digit product format
- 715580590
- Labeler code
- 71558
- Product ID
- 71558-590_9f8bbe4b-d496-41c7-85c6-470f0e83c2d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amikacin
- Dosage form
- SUSPENSION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Insmed Incorporated
- Application
- NDA207356
- Marketing category
- NDA
- Marketing start
- 2018-10-12
- Substance
- AMIKACIN
- Active strength
- 590 mg/8.4mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ARIKAYCE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIKACIN | 590 mg/8.4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 84319SGC3C |
| Rxcui | 2059184, 2059189 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71558-590-28 | ARIKAYCE | 28 in 1 CARTON | SUSPENSION | 28 | | 14 |
| 71558-590-28 | ARIKAYCE | 8.4 mL in 1 VIAL | SUSPENSION | 8.4 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71558-590 | ARIKAYCE (AMIKACIN) SUSPENSION [INSMED INCORPORATED] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250327_499ab990-2b21-474f-aaba-d86388965f40.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 |
|---|
| 71558-590-28 | 71558059028 | 28 VIAL in 1 CARTON (71558-590-28) / 8.4 mL in 1 VIAL | 28 vial | 2018-10-12 | 0000-00-00 | No | No | Current |