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NDC 00078-0953-26 TobraDex 1; 3 mg/mL; mg/mL Details
TobraDex 1; 3 mg/mL; mg/mL
TobraDex is a OPHTHALMIC SUSPENSION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is DEXAMETHASONE; TOBRAMYCIN.
MedlinePlus Drug Summary
Dexamethasone reduces the irritation, redness, burning, and swelling of eye caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It is sometimes used after eye surgery.
Related Packages: 00078-0953-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dexamethasone Ophthalmic
Ophthalmic tobramycin is used to treat eye infections. Tobramycin is in a class of medications called antibiotics. It works by killing bacteria that cause infections.
Related Packages: 00078-0953-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tobramycin Ophthalmic
Product Information
| NDC | 00078-0953 |
|---|---|
| Product ID | 0078-0953_3b30de62-e2a2-4609-9c58-26cb07135ffc |
| Associated GPIs | |
| GCN Sequence Number | 007986 |
| GCN Sequence Number Description | tobramycin/dexamethasone DROPS SUSP 0.3 %-0.1% OPHTHALMIC |
| HIC3 | Q6I |
| HIC3 Description | EYE ANTIBIOTIC AND GLUCOCORTICOID COMBINATIONS |
| GCN | 92280 |
| HICL Sequence Number | 039399 |
| HICL Sequence Number Description | TOBRAMYCIN/DEXAMETHASONE |
| Brand/Generic | Brand |
| Proprietary Name | TobraDex |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tobramycin and dexamethasone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 1; 3 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | DEXAMETHASONE; TOBRAMYCIN |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050592 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0953-26 (00078095326)
| NDC Package Code | 0078-0953-26 |
|---|---|
| Billing NDC | 00078095326 |
| Package | 10 mL in 1 BOTTLE (0078-0953-26) |
| Marketing Start Date | 2022-01-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |