tobramycin

Generic: tobramycin

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

tobramycin 3 mg/mL

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0341
Product ID 80425-0341_2862f6ad-689c-d683-e063-6394a90a89d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064052
Listing Expiration 2026-12-31
Marketing Start 2023-05-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250341
Hyphenated Format 80425-0341

Supplemental Identifiers

RxCUI
313415
UNII
VZ8RRZ51VK
NUI
N0000175477 M0000946

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 ANDA064052 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (80425-0341-1) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

80425-0341-1 1 BOTTLE, DROPPER in 1 CARTON (80425-0341-1) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

tobramycin (3 mg/mL)

Linked Drug Pages (1)

Tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2862f6ad-689c-d683-e063-6394a90a89d1", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["313415"], "spl_set_id": ["fc734c2d-0d45-195c-e053-6394a90a2a92"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (80425-0341-1)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "80425-0341-1", "marketing_start_date": "20230524"}], "brand_name": "Tobramycin", "product_id": "80425-0341_2862f6ad-689c-d683-e063-6394a90a89d1", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "80425-0341", "generic_name": "Tobramycin", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "ANDA064052", "marketing_category": "ANDA", "marketing_start_date": "20230524", "listing_expiration_date": "20261231"}