tobramycin ophthalmic solution

Generic: tobramycin ophthalmic solution

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin ophthalmic solution
Generic Name tobramycin ophthalmic solution
Labeler alembic pharmaceuticals limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tobramycin 3 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-518
Product ID 46708-518_14c14f81-6b0a-4176-a5df-d0757cc3260d
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 46708518
Hyphenated Format 46708-518

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 (46708-518-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

46708-518-05 1 BOTTLE in 1 CARTON (46708-518-05) / 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": "14c14f81-6b0a-4176-a5df-d0757cc3260d", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["313415"], "spl_set_id": ["14c14f81-6b0a-4176-a5df-d0757cc3260d"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-518-05)  / 5 mL in 1 BOTTLE", "package_ndc": "46708-518-05", "marketing_start_date": "20190419"}], "brand_name": "Tobramycin Ophthalmic Solution", "product_id": "46708-518_14c14f81-6b0a-4176-a5df-d0757cc3260d", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "46708-518", "generic_name": "Tobramycin Ophthalmic Solution", "labeler_name": "Alembic Pharmaceuticals Limited", "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"}