tobramycin ophthalmic solution (62332-518)

Drug Facts

Product Profile

Brand Name tobramycin ophthalmic solution

Generic Name tobramycin ophthalmic solution

Labeler alembic pharmaceuticals inc.

Dosage Form SOLUTION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

tobramycin 3 mg/mL

Manufacturer

Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-518

Product ID 62332-518_5d11cea7-cb06-4ab9-930d-190549b2f4ca

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211847

Listing Expiration 2026-12-31

Marketing Start 2019-04-19

Pharmacologic Class

Established (EPC)

aminoglycoside antibacterial [epc]

Chemical Structure

aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332518

Hyphenated Format 62332-518

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 ophthalmic solution (source: ndc)

Generic Name tobramycin ophthalmic solution (source: ndc)

Application Number ANDA211847 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

3 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (62332-518-05) / 5 mL in 1 BOTTLE

source: ndc

Packages (1)

62332-518-05 1 BOTTLE in 1 CARTON (62332-518-05) / 5 mL in 1 BOTTLE

Ingredients (1)

tobramycin (3 mg/mL)

Linked Drug Pages (1)

Tobramycin Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "5d11cea7-cb06-4ab9-930d-190549b2f4ca", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["313415"], "spl_set_id": ["3c23234a-452b-40d0-922f-37e49147d537"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (62332-518-05)  / 5 mL in 1 BOTTLE", "package_ndc": "62332-518-05", "marketing_start_date": "20190419"}], "brand_name": "Tobramycin Ophthalmic Solution", "product_id": "62332-518_5d11cea7-cb06-4ab9-930d-190549b2f4ca", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "62332-518", "generic_name": "Tobramycin Ophthalmic Solution", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin Ophthalmic Solution", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "ANDA211847", "marketing_category": "ANDA", "marketing_start_date": "20190419", "listing_expiration_date": "20261231"}