tobramycin

Generic: tobramycin

Labeler: xiromed llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler xiromed llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tobramycin sulfate 1.2 g/30mL

Manufacturer
Xiromed LLC

Identifiers & Regulatory

Product NDC 70700-173
Product ID 70700-173_85d94342-3699-d4cb-69f5-391593a54ebe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211189
Listing Expiration 2026-12-31
Marketing Start 2021-07-12

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700173
Hyphenated Format 70700-173

Supplemental Identifiers

RxCUI
597823
UNII
HJT0RXD7JK

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 ANDA211189 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.2 g/30mL
source: ndc
Packaging
  • 6 CARTON in 1 CARTON (70700-173-86) / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-173-22) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (1)

70700-173-86 6 CARTON in 1 CARTON (70700-173-86) / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-173-22) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE

Ingredients (1)

tobramycin sulfate (1.2 g/30mL)

Linked Drug Pages (1)

Tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "85d94342-3699-d4cb-69f5-391593a54ebe", "openfda": {"unii": ["HJT0RXD7JK"], "rxcui": ["597823"], "spl_set_id": ["8b50d1b5-ea8a-5844-358a-493f1965c07f"], "manufacturer_name": ["Xiromed LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 CARTON in 1 CARTON (70700-173-86)  / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-173-22)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "70700-173-86", "marketing_start_date": "20230120"}], "brand_name": "Tobramycin", "product_id": "70700-173_85d94342-3699-d4cb-69f5-391593a54ebe", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "70700-173", "generic_name": "Tobramycin", "labeler_name": "Xiromed LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN SULFATE", "strength": "1.2 g/30mL"}], "application_number": "ANDA211189", "marketing_category": "ANDA", "marketing_start_date": "20210712", "listing_expiration_date": "20261231"}