tobramycin

Generic: tobramycin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-129
Product ID 59651-129_faec0c96-e264-6fee-e053-6394a90a23ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210871
Listing Expiration 2026-12-31
Marketing Start 2021-01-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651129
Hyphenated Format 59651-129

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 ANDA210871 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

59651-129-56 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 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": "faec0c96-e264-6fee-e053-6394a90a23ca", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719"], "spl_set_id": ["0aa5859e-cd80-49c0-881b-47f39d1f1d01"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (59651-129-56)  / 4 AMPULE in 1 POUCH (59651-129-04)  / 5 mL in 1 AMPULE", "package_ndc": "59651-129-56", "marketing_start_date": "20210122"}], "brand_name": "TOBRAMYCIN", "product_id": "59651-129_faec0c96-e264-6fee-e053-6394a90a23ca", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "59651-129", "generic_name": "TOBRAMYCIN", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOBRAMYCIN", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "ANDA210871", "marketing_category": "ANDA", "marketing_start_date": "20210122", "listing_expiration_date": "20261231"}