kitabis pak

Generic: tobramycin

Labeler: pari respiratory equipment, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kitabis pak
Generic Name tobramycin
Labeler pari respiratory equipment, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/5mL

Manufacturer
Pari Respiratory Equipment, Inc.

Identifiers & Regulatory

Product NDC 24492-850
Product ID 24492-850_49aa9935-4371-43a5-a681-f7a5725b1b2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205433
Listing Expiration 2026-12-31
Marketing Start 2015-02-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24492850
Hyphenated Format 24492-850

Supplemental Identifiers

RxCUI
348719 1596030
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 kitabis 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 (24492-850-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
source: ndc

Packages (1)

24492-850-56 14 POUCH in 1 CARTON (24492-850-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

Ingredients (1)

tobramycin (300 mg/5mL)

Linked Drug Pages (1)

Kitabis Pak ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "49aa9935-4371-43a5-a681-f7a5725b1b2b", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719", "1596030"], "spl_set_id": ["da1e5afd-d707-4af1-8935-8195ba6d769f"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Pari Respiratory Equipment, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (24492-850-56)  / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE", "package_ndc": "24492-850-56", "marketing_start_date": "20150219"}], "brand_name": "Kitabis Pak", "product_id": "24492-850_49aa9935-4371-43a5-a681-f7a5725b1b2b", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "24492-850", "generic_name": "Tobramycin", "labeler_name": "Pari Respiratory Equipment, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kitabis Pak", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "NDA205433", "marketing_category": "NDA", "marketing_start_date": "20150219", "listing_expiration_date": "20261231"}