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NDC 00078-0771-01 MAXITROL 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Details
MAXITROL 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g
MAXITROL is a OPHTHALMIC OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.
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: 00078-0771-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dexamethasone Ophthalmic
Neomycin, polymyxin, and bacitracin ophthalmic combination is used to treat eye and eyelid infections. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria infecting a surface of the eye.
Related Packages: 00078-0771-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Ophthalmic
Product Information
| NDC | 00078-0771 |
|---|---|
| Product ID | 0078-0771_06ba06c5-1c25-4f68-b1e9-cffcf0409c90 |
| Associated GPIs | 86309903324210 |
| GCN Sequence Number | 048546 |
| GCN Sequence Number Description | neomycin/polymyxin B/dexametha OINT. (G) 3.5-10K-.1 OPHTHALMIC |
| HIC3 | Q6I |
| HIC3 Description | EYE ANTIBIOTIC AND GLUCOCORTICOID COMBINATIONS |
| GCN | 14285 |
| HICL Sequence Number | 003523 |
| HICL Sequence Number Description | NEOMYCIN/POLYMYXIN B SULFATE/DEXAMETHASONE |
| Brand/Generic | Brand |
| Proprietary Name | MAXITROL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | neomycin sulfate, polymyxin b sulfate and dexamethasone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | OINTMENT |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 1; 3.5; 10000 |
| Active Ingredient Units | mg/g; mg/g; [USP'U]/g |
| Substance Name | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050065 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0771-01 (00078077101)
| NDC Package Code | 0078-0771-01 |
|---|---|
| Billing NDC | 00078077101 |
| Package | 3.5 g in 1 TUBE (0078-0771-01) |
| Marketing Start Date | 2020-08-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |