tobramycin inhalation solution (43598-605)

Drug Facts

Product Profile

Brand Name tobramycin inhalation solution

Generic Name tobramycin inhalation solution

Labeler dr. reddy's laboratories inc.

Dosage Form INHALANT

Routes

RESPIRATORY (INHALATION)

Active Ingredients

tobramycin 300 mg/5mL

Manufacturer

Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-605

Product ID 43598-605_946d18e8-ea8f-97c0-f49b-ec4e286beede

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207080

Listing Expiration 2026-12-31

Marketing Start 2019-05-14

Pharmacologic Class

Established (EPC)

aminoglycoside antibacterial [epc]

Chemical Structure

aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598605

Hyphenated Format 43598-605

Supplemental Identifiers

RxCUI

348719

UPC

0343598605111

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 (source: ndc)

Generic Name tobramycin inhalation solution (source: ndc)

Application Number ANDA207080 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

300 mg/5mL

source: ndc

Packaging

14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE
56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE

source: ndc

Packages (2)

43598-605-56 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE 43598-605-58 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE

Ingredients (1)

tobramycin (300 mg/5mL)

Linked Drug Pages (1)

Tobramycin Inhalation Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "946d18e8-ea8f-97c0-f49b-ec4e286beede", "openfda": {"nui": ["N0000175477", "M0000946"], "upc": ["0343598605111"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719"], "spl_set_id": ["e5bbf589-d066-c89a-c40f-cbeb6f98c5b5"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (43598-605-56)  / 4 AMPULE in 1 POUCH (43598-605-04)  / 5 mL in 1 AMPULE", "package_ndc": "43598-605-56", "marketing_start_date": "20190514"}, {"sample": false, "description": "56 POUCH in 1 CARTON (43598-605-58)  / 1 AMPULE in 1 POUCH (43598-605-11)  / 5 mL in 1 AMPULE", "package_ndc": "43598-605-58", "marketing_start_date": "20201029"}], "brand_name": "Tobramycin Inhalation Solution", "product_id": "43598-605_946d18e8-ea8f-97c0-f49b-ec4e286beede", "dosage_form": "INHALANT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "43598-605", "generic_name": "Tobramycin Inhalation Solution", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin Inhalation Solution", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "ANDA207080", "marketing_category": "ANDA", "marketing_start_date": "20190514", "listing_expiration_date": "20261231"}