tobi podhaler

Generic: tobramycin

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobi podhaler
Generic Name tobramycin
Labeler viatris specialty llc
Dosage Form CAPSULE
Routes
ORAL RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 28 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 49502-401
Product ID 49502-401_0ebb786f-98a7-47b4-a0ef-06c0412ca3da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201688
Listing Expiration 2026-12-31
Marketing Start 2021-09-01

Pharmacologic Class

Established (EPC)
aminoglycoside antibacterial [epc]
Chemical Structure
aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49502401
Hyphenated Format 49502-401

Supplemental Identifiers

RxCUI
1374569 1374570 1374573 1374574 1661466 1661559 1661560 1661567
UNII
VZ8RRZ51VK
NUI
N0000175477 M0000946

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tobi podhaler (source: ndc)
Generic Name tobramycin (source: ndc)
Application Number NDA201688 (source: ndc)
Routes
ORAL RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 28 mg/1
source: ndc
Packaging
  • 8 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09)
  • 224 PACKAGE in 1 BOX, UNIT-DOSE (49502-401-24) / 56 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK
  • 7 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-401-57) / 8 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (3)

49502-401-09 8 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09) 49502-401-24 224 PACKAGE in 1 BOX, UNIT-DOSE (49502-401-24) / 56 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK 49502-401-57 7 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-401-57) / 8 CAPSULE in 1 BLISTER PACK

Ingredients (1)

tobramycin (28 mg/1)

Linked Drug Pages (1)

TOBI Podhaler ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RESPIRATORY (INHALATION)"], "spl_id": "0ebb786f-98a7-47b4-a0ef-06c0412ca3da", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["1374569", "1374570", "1374573", "1374574", "1661466", "1661559", "1661560", "1661567"], "spl_set_id": ["c4b5bb1f-e158-4ac1-9c35-e98a416c743a"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "8 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09)", "package_ndc": "49502-401-09", "marketing_start_date": "20221004"}, {"sample": false, "description": "224 PACKAGE in 1 BOX, UNIT-DOSE (49502-401-24)  / 56 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK", "package_ndc": "49502-401-24", "marketing_start_date": "20210901"}, {"sample": true, "description": "7 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-401-57)  / 8 CAPSULE in 1 BLISTER PACK", "package_ndc": "49502-401-57", "marketing_start_date": "20221004"}], "brand_name": "TOBI Podhaler", "product_id": "49502-401_0ebb786f-98a7-47b4-a0ef-06c0412ca3da", "dosage_form": "CAPSULE", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "49502-401", "generic_name": "Tobramycin", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOBI Podhaler", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "28 mg/1"}], "application_number": "NDA201688", "marketing_category": "NDA", "marketing_start_date": "20210901", "listing_expiration_date": "20261231"}