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NDC 10122-0820-28 BETHKIS 300 mg/4mL Details
BETHKIS 300 mg/4mL
BETHKIS is a RESPIRATORY (INHALATION) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Chiesi USA, Inc.. The primary component is TOBRAMYCIN.
Product Information
| NDC | 10122-0820 |
|---|---|
| Product ID | 10122-820_32442297-00c4-4800-b7c4-1e2e290f3162 |
| Associated GPIs | 07000070002530 |
| GCN Sequence Number | 064682 |
| GCN Sequence Number Description | tobramycin AMPUL-NEB 300 MG/4ML INHALATION |
| HIC3 | W1F |
| HIC3 Description | AMINOGLYCOSIDE ANTIBIOTICS |
| GCN | 16122 |
| HICL Sequence Number | 017765 |
| HICL Sequence Number Description | TOBRAMYCIN |
| Brand/Generic | Brand |
| Proprietary Name | BETHKIS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tobramycin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/4mL |
| Substance Name | TOBRAMYCIN |
| Labeler Name | Chiesi USA, Inc. |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA201820 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 10122-0820-28 (10122082028)
| NDC Package Code | 10122-820-28 |
|---|---|
| Billing NDC | 10122082028 |
| Package | 7 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE |
| Marketing Start Date | 2013-04-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |