tobramycin

Generic: tobramycin

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

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tobramycin sulfate 1.2 g/30mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-312
Product ID 68083-312_a13f2109-eb69-4d3a-9203-790cb6520e78
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211189
Listing Expiration 2026-12-31
Marketing Start 2021-05-18

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083312
Hyphenated Format 68083-312

Supplemental Identifiers

RxCUI
597823
UPC
0368083312060
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 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-312-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (68083-312-01)
source: ndc

Packages (1)

68083-312-06 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-312-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (68083-312-01)

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": "a13f2109-eb69-4d3a-9203-790cb6520e78", "openfda": {"upc": ["0368083312060"], "unii": ["HJT0RXD7JK"], "rxcui": ["597823"], "spl_set_id": ["38219f34-4859-428f-9ec1-06ead7604211"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-312-06)  / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (68083-312-01)", "package_ndc": "68083-312-06", "marketing_start_date": "20210518"}], "brand_name": "Tobramycin", "product_id": "68083-312_a13f2109-eb69-4d3a-9203-790cb6520e78", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "68083-312", "generic_name": "Tobramycin", "labeler_name": "Gland Pharma Limited", "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": "20210518", "listing_expiration_date": "20261231"}