tobramycin

Generic: tobramycin

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

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler belcher pharmaceuticals, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tobramycin 3 mg/mL

Manufacturer
Belcher Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 62250-110
Product ID 62250-110_f2495e4f-4ffe-4e14-bcb3-f72f1da932a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212628
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62250110
Hyphenated Format 62250-110

Supplemental Identifiers

RxCUI
313415
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 ANDA212628 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (62250-110-01) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

62250-110-01 1 BOTTLE, PLASTIC in 1 CARTON (62250-110-01) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

tobramycin (3 mg/mL)

Linked Drug Pages (1)

Tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "f2495e4f-4ffe-4e14-bcb3-f72f1da932a6", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["313415"], "spl_set_id": ["17b5b083-79ab-46b5-bed6-866e5415c623"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Belcher Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (62250-110-01)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "62250-110-01", "marketing_start_date": "20240401"}], "brand_name": "Tobramycin", "product_id": "62250-110_f2495e4f-4ffe-4e14-bcb3-f72f1da932a6", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "62250-110", "generic_name": "Tobramycin", "labeler_name": "Belcher Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "ANDA212628", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}