tobramycin

Generic: tobramycin

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler xgen pharmaceuticals djb, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tobramycin sulfate 1.2 g/30mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-0412
Product ID 39822-0412_40a90656-9bc2-494b-e063-6294a90a04f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065013
Listing Expiration 2027-12-31
Marketing Start 2001-08-17

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 398220412
Hyphenated Format 39822-0412

Supplemental Identifiers

RxCUI
597823
UPC
0339822041213 0339822041268
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 ANDA065013 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.2 g/30mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL
  • 6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL
source: ndc

Packages (2)

39822-0412-1 1 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL 39822-0412-6 6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL

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": "40a90656-9bc2-494b-e063-6294a90a04f2", "openfda": {"upc": ["0339822041213", "0339822041268"], "unii": ["HJT0RXD7JK"], "rxcui": ["597823"], "spl_set_id": ["a384641c-04e3-4ab5-b152-7408cd07b64d"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (39822-0412-1)  / 30 mL in 1 VIAL", "package_ndc": "39822-0412-1", "marketing_start_date": "20010817"}, {"sample": false, "description": "6 VIAL in 1 CARTON (39822-0412-6)  / 30 mL in 1 VIAL", "package_ndc": "39822-0412-6", "marketing_start_date": "20010817"}], "brand_name": "Tobramycin", "product_id": "39822-0412_40a90656-9bc2-494b-e063-6294a90a04f2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "39822-0412", "generic_name": "Tobramycin", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN SULFATE", "strength": "1.2 g/30mL"}], "application_number": "ANDA065013", "marketing_category": "ANDA", "marketing_start_date": "20010817", "listing_expiration_date": "20271231"}