tobramycin inhalation solution pak

Generic: tobramycin

Labeler: genericus, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin inhalation solution pak
Generic Name tobramycin
Labeler genericus, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/5mL

Manufacturer
Genericus, Inc.

Identifiers & Regulatory

Product NDC 70644-899
Product ID 70644-899_aeeb7c89-484f-4429-a5d5-0025d19745fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA205433
Listing Expiration 2026-12-31
Marketing Start 2016-07-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70644899
Hyphenated Format 70644-899

Supplemental Identifiers

RxCUI
348719
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 tobramycin inhalation solution pak (source: ndc)
Generic Name tobramycin (source: ndc)
Application Number NDA205433 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
source: ndc

Packages (1)

70644-899-99 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

Ingredients (1)

tobramycin (300 mg/5mL)

Linked Drug Pages (1)

Tobramycin Inhalation Solution Pak ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "aeeb7c89-484f-4429-a5d5-0025d19745fd", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719"], "spl_set_id": ["dad13445-f591-4829-96f9-1598ba03dff8"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Genericus, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (70644-899-99)  / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE", "package_ndc": "70644-899-99", "marketing_start_date": "20160711"}], "brand_name": "Tobramycin Inhalation Solution Pak", "product_id": "70644-899_aeeb7c89-484f-4429-a5d5-0025d19745fd", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "70644-899", "generic_name": "Tobramycin", "labeler_name": "Genericus, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "brand_name_suffix": "Inhalation Solution Pak", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "NDA205433", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20160711", "listing_expiration_date": "20261231"}