tobramycin

Generic: tobramycin

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler sandoz inc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

tobramycin 3 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-643
Product ID 61314-643_505c82ff-86c3-4269-96cb-faae872c7539
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062535
Listing Expiration 2026-12-31
Marketing Start 1995-01-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314643
Hyphenated Format 61314-643

Supplemental Identifiers

RxCUI
313415
UPC
0361314643056
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 ANDA062535 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, PLASTIC (61314-643-05)
source: ndc

Packages (1)

61314-643-05 5 mL in 1 BOTTLE, PLASTIC (61314-643-05)

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": "505c82ff-86c3-4269-96cb-faae872c7539", "openfda": {"nui": ["N0000175477", "M0000946"], "upc": ["0361314643056"], "unii": ["VZ8RRZ51VK"], "rxcui": ["313415"], "spl_set_id": ["27e2c16e-19b0-4745-93eb-5cf99f94bb92"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (61314-643-05)", "package_ndc": "61314-643-05", "marketing_start_date": "19950109"}], "brand_name": "Tobramycin", "product_id": "61314-643_505c82ff-86c3-4269-96cb-faae872c7539", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "61314-643", "generic_name": "Tobramycin", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "ANDA062535", "marketing_category": "ANDA", "marketing_start_date": "19950109", "listing_expiration_date": "20261231"}