tobramycin

Generic: tobramycin

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/5mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-171
Product ID 47335-171_fcccf0aa-4457-4836-a74f-594614cbb4a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207136
Listing Expiration 2026-12-31
Marketing Start 2020-02-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335171
Hyphenated Format 47335-171

Supplemental Identifiers

RxCUI
348719
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 ANDA207136 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

47335-171-49 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 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": "fcccf0aa-4457-4836-a74f-594614cbb4a3", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719"], "spl_set_id": ["c452e428-0d8f-4f35-b98f-5aa3b814cb49"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (47335-171-49)  / 4 AMPULE in 1 POUCH (47335-171-48)  / 5 mL in 1 AMPULE", "package_ndc": "47335-171-49", "marketing_start_date": "20200228"}], "brand_name": "Tobramycin", "product_id": "47335-171_fcccf0aa-4457-4836-a74f-594614cbb4a3", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "47335-171", "generic_name": "Tobramycin", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "ANDA207136", "marketing_category": "ANDA", "marketing_start_date": "20200228", "listing_expiration_date": "20261231"}