tobramycin

Generic: tobramycin

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler amneal pharmaceuticals llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-914
Product ID 65162-914_609a53df-fb3c-4349-8ada-22b985d2c4ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205501
Listing Expiration 2026-12-31
Marketing Start 2014-07-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162914
Hyphenated Format 65162-914

Supplemental Identifiers

RxCUI
348719
UPC
0365162914467
UNII
VZ8RRZ51VK
NUI
N0000175477 M0000946

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 ANDA205501 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

65162-914-46 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE

Ingredients (1)

tobramycin (300 mg/5mL)

Linked Drug Pages (1)

Tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "609a53df-fb3c-4349-8ada-22b985d2c4ac", "openfda": {"nui": ["N0000175477", "M0000946"], "upc": ["0365162914467"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719"], "spl_set_id": ["15f9c0cd-7dbf-4a91-9961-14f1dd000343"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 AMPULE in 1 CARTON (65162-914-46)  / 5 mL in 1 AMPULE", "package_ndc": "65162-914-46", "marketing_start_date": "20140713"}], "brand_name": "Tobramycin", "product_id": "65162-914_609a53df-fb3c-4349-8ada-22b985d2c4ac", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "65162-914", "generic_name": "Tobramycin", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "ANDA205501", "marketing_category": "ANDA", "marketing_start_date": "20140713", "listing_expiration_date": "20261231"}