tobramycin

Generic: tobramycin

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler northstar rxllc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/5mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-430
Product ID 72603-430_0d806a34-e83d-4ce4-9da2-1630c49790a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214478
Listing Expiration 2026-12-31
Marketing Start 2024-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603430
Hyphenated Format 72603-430

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 (source: ndc)
Generic Name tobramycin (source: ndc)
Application Number ANDA214478 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

72603-430-56 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE

Ingredients (1)

tobramycin (300 mg/5mL)

Linked Drug Pages (1)

TOBRAMYCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "0d806a34-e83d-4ce4-9da2-1630c49790a8", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719"], "spl_set_id": ["7803ac83-1250-451b-8ad8-2c0a343c3031"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (72603-430-56)  / 4 AMPULE in 1 POUCH (72603-430-04)  / 5 mL in 1 AMPULE", "package_ndc": "72603-430-56", "marketing_start_date": "20240801"}], "brand_name": "TOBRAMYCIN", "product_id": "72603-430_0d806a34-e83d-4ce4-9da2-1630c49790a8", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "72603-430", "generic_name": "Tobramycin", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOBRAMYCIN", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "ANDA214478", "marketing_category": "ANDA", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}