tobramycin

Generic: tobramycin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler proficient rx lp
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tobramycin 3 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-902
Product ID 63187-902_f1b5aa19-119f-4d5a-aa8d-8f3778a48753
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064096
Listing Expiration 2026-12-31
Marketing Start 1996-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187902
Hyphenated Format 63187-902

Supplemental Identifiers

RxCUI
313415
UNII
VZ8RRZ51VK
NUI
N0000175477 M0000946

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 ANDA064096 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (63187-902-02) / 2 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (63187-902-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

63187-902-02 1 BOTTLE, DROPPER in 1 CARTON (63187-902-02) / 2 mL in 1 BOTTLE, DROPPER 63187-902-05 1 BOTTLE, DROPPER in 1 CARTON (63187-902-05) / 5 mL in 1 BOTTLE, DROPPER

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": "f1b5aa19-119f-4d5a-aa8d-8f3778a48753", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["313415"], "spl_set_id": ["ac497300-eb1e-4021-b504-89f19e1eb0f3"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63187-902-02)  / 2 mL in 1 BOTTLE, DROPPER", "package_ndc": "63187-902-02", "marketing_start_date": "20170901"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63187-902-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "63187-902-05", "marketing_start_date": "20170901"}], "brand_name": "Tobramycin", "product_id": "63187-902_f1b5aa19-119f-4d5a-aa8d-8f3778a48753", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63187-902", "generic_name": "Tobramycin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "ANDA064096", "marketing_category": "ANDA", "marketing_start_date": "19960131", "listing_expiration_date": "20261231"}