tobramycin

Generic: tobramycin solution

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin solution
Labeler micro labs limited
Dosage Form INHALANT
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/5mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-408
Product ID 42571-408_38f21173-d355-80a7-e063-6294a90a3643
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217344
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571408
Hyphenated Format 42571-408

Supplemental Identifiers

RxCUI
348719
UPC
0342571408190
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 solution (source: ndc)
Application Number ANDA217344 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09)
source: ndc

Packages (1)

42571-408-92 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09)

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": "38f21173-d355-80a7-e063-6294a90a3643", "openfda": {"nui": ["N0000175477", "M0000946"], "upc": ["0342571408190"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719"], "spl_set_id": ["9d8b7b6c-3072-48e9-87c8-51160b9df9bc"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (42571-408-92)  / 4 AMPULE in 1 POUCH (42571-408-19)  / 5 mL in 1 AMPULE (42571-408-09)", "package_ndc": "42571-408-92", "marketing_start_date": "20240101"}], "brand_name": "Tobramycin", "product_id": "42571-408_38f21173-d355-80a7-e063-6294a90a3643", "dosage_form": "INHALANT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "42571-408", "generic_name": "Tobramycin solution", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "ANDA217344", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}