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
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

tobramycin sulfate 40 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-254
Product ID 68083-254_5af7f80d-4d6d-404f-9ff7-1a8315625d8b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209621
Listing Expiration 2026-12-31
Marketing Start 2021-02-11

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083254
Hyphenated Format 68083-254

Supplemental Identifiers

RxCUI
313416 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 ANDA209621 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (68083-254-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-254-01)
source: ndc

Packages (1)

68083-254-25 25 VIAL, MULTI-DOSE in 1 CARTON (68083-254-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-254-01)

Ingredients (1)

tobramycin sulfate (40 mg/mL)

Linked Drug Pages (1)

Tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "5af7f80d-4d6d-404f-9ff7-1a8315625d8b", "openfda": {"unii": ["HJT0RXD7JK"], "rxcui": ["313416", "597823"], "spl_set_id": ["645d34d9-275d-428e-863d-ae15ad009c44"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (68083-254-25)  / 2 mL in 1 VIAL, MULTI-DOSE (68083-254-01)", "package_ndc": "68083-254-25", "marketing_start_date": "20210211"}], "brand_name": "Tobramycin", "product_id": "68083-254_5af7f80d-4d6d-404f-9ff7-1a8315625d8b", "dosage_form": "INJECTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "68083-254", "generic_name": "Tobramycin", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN SULFATE", "strength": "40 mg/mL"}], "application_number": "ANDA209621", "marketing_category": "ANDA", "marketing_start_date": "20210211", "listing_expiration_date": "20261231"}