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NDC 49502-0401-09 TOBI Podhaler 28 mg/1 Details
TOBI Podhaler 28 mg/1
TOBI Podhaler is a ORAL; RESPIRATORY (INHALATION) CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Specialty L.P.. The primary component is TOBRAMYCIN.
Product Information
NDC | 49502-0401 |
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Product ID | 49502-401_0fd51b21-02ae-4b86-a817-4352a9899256 |
Associated GPIs | 07000070000120 |
GCN Sequence Number | 067462 |
GCN Sequence Number Description | tobramycin CAP W/DEV 28 MG INHALATION |
HIC3 | W1F |
HIC3 Description | AMINOGLYCOSIDE ANTIBIOTICS |
GCN | 30025 |
HICL Sequence Number | 017765 |
HICL Sequence Number Description | TOBRAMYCIN |
Brand/Generic | Brand |
Proprietary Name | TOBI Podhaler |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Tobramycin |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | CAPSULE |
Route | ORAL; RESPIRATORY (INHALATION) |
Active Ingredient Strength | 28 |
Active Ingredient Units | mg/1 |
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 | NDA201688 |
Listing Certified Through | n/a |
Package
NDC 49502-0401-09 (49502040109)
NDC Package Code | 49502-401-09 |
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Billing NDC | 49502040109 |
Package | 8 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09) |
Marketing Start Date | 2022-10-04 |
NDC Exclude Flag | N |
Pricing Information | N/A |