tobramycin

Generic: tobramycin

Labeler: directrx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler directrx
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tobramycin 3 mg/mL

Manufacturer
DirectRX

Identifiers & Regulatory

Product NDC 61919-642
Product ID 61919-642_0e98b2f4-6caf-f58b-e063-6394a90ab0ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207444
Listing Expiration 2026-12-31
Marketing Start 2019-04-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919642
Hyphenated Format 61919-642

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 ANDA207444 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (61919-642-05)
source: ndc

Packages (1)

61919-642-05 5 mL in 1 BOTTLE (61919-642-05)

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": "0e98b2f4-6caf-f58b-e063-6394a90ab0ab", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["313415"], "spl_set_id": ["87349ae8-4709-7f5a-e053-2a91aa0ae3d1"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["DirectRX"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (61919-642-05)", "package_ndc": "61919-642-05", "marketing_start_date": "20190423"}], "brand_name": "TOBRAMYCIN", "product_id": "61919-642_0e98b2f4-6caf-f58b-e063-6394a90ab0ab", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "61919-642", "generic_name": "TOBRAMYCIN", "labeler_name": "DirectRX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOBRAMYCIN", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "ANDA207444", "marketing_category": "ANDA", "marketing_start_date": "20190423", "listing_expiration_date": "20261231"}