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NDC 49502-0345-73 TOBI 300 mg/5mL Details
TOBI 300 mg/5mL
TOBI is a ORAL; RESPIRATORY (INHALATION) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Specialty L.P.. The primary component is TOBRAMYCIN.
Product Information
| NDC | 49502-0345 |
|---|---|
| Product ID | 49502-345_8061b21d-5a04-48c1-b0fe-f769560f4a59 |
| Associated GPIs | 07000070002520 |
| GCN Sequence Number | 037042 |
| GCN Sequence Number Description | tobramycin in 0.225% sod chlor AMPUL-NEB 300 MG/5ML INHALATION |
| HIC3 | W1F |
| HIC3 Description | AMINOGLYCOSIDE ANTIBIOTICS |
| GCN | 61551 |
| HICL Sequence Number | 016926 |
| HICL Sequence Number Description | TOBRAMYCIN IN 0.225 % SODIUM CHLORIDE |
| Brand/Generic | Brand |
| Proprietary Name | TOBI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tobramycin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL; RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/5mL |
| Substance Name | TOBRAMYCIN |
| Labeler Name | Mylan Specialty L.P. |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050753 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 49502-0345-73 (49502034573)
| NDC Package Code | 49502-345-73 |
|---|---|
| Billing NDC | 49502034573 |
| Package | 56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULE |
| Marketing Start Date | 2022-06-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |