gentamicin sulfate

Generic: gentamicin sulfate

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin sulfate
Generic Name gentamicin sulfate
Labeler cosette pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

gentamicin sulfate 1 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0683
Product ID 0713-0683_0abc5db4-9344-8946-e063-6394a90abf1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064056
Listing Expiration 2026-12-31
Marketing Start 2016-11-11

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130683
Hyphenated Format 0713-0683

Supplemental Identifiers

RxCUI
197735
UNII
8X7386QRLV

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 gentamicin sulfate (source: ndc)
Generic Name gentamicin sulfate (source: ndc)
Application Number ANDA064056 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0683-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0683-31) / 30 g in 1 TUBE
source: ndc

Packages (2)

0713-0683-15 1 TUBE in 1 CARTON (0713-0683-15) / 15 g in 1 TUBE 0713-0683-31 1 TUBE in 1 CARTON (0713-0683-31) / 30 g in 1 TUBE

Ingredients (1)

gentamicin sulfate (1 mg/g)

Linked Drug Pages (1)

Gentamicin Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0abc5db4-9344-8946-e063-6394a90abf1c", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["197735"], "spl_set_id": ["9e550dc9-509e-da05-8a97-ecbd0f5dd633"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0683-15)  / 15 g in 1 TUBE", "package_ndc": "0713-0683-15", "marketing_start_date": "20161111"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0683-31)  / 30 g in 1 TUBE", "package_ndc": "0713-0683-31", "marketing_start_date": "20161111"}], "brand_name": "Gentamicin Sulfate", "product_id": "0713-0683_0abc5db4-9344-8946-e063-6394a90abf1c", "dosage_form": "CREAM", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "0713-0683", "generic_name": "Gentamicin Sulfate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "1 mg/g"}], "application_number": "ANDA064056", "marketing_category": "ANDA", "marketing_start_date": "20161111", "listing_expiration_date": "20261231"}