Prescription drug · NDA
Maxitrol NDC 82667-100
neomycin sulfate, polymyxin b sulfate and dexamethasone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Suspension · Ophthalmic · Harrow Eye, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82667-100-05 | 82667010005 | 5 mL in 1 BOTTLE, PLASTIC (82667-100-05)Marketed from Nov 1, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Maxitrol
- Generic name (nonproprietary)
- neomycin sulfate, polymyxin b sulfate and dexamethasone
- Active ingredients
- Neomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [USP'U]/mLDexamethasone — 1 mg/mL
- Dosage form
- Suspension
- Route
- Ophthalmic
- Labeler
- Harrow Eye, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050023
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 82667-100_41ef9a7f-c1aa-de10-e063-6394a90adeecSPL ID 41ef9a7f-c1aa-de10-e063-6394a90adeecSPL set ID ecfb954f-5554-0ad2-e053-2995a90a7516RxCUI 208591, 309680UNII 057Y626693, 19371312D4, 7S5I7G3JQLUPC 0382667100058
- Pharmacologic class
- Aminoglycoside Antibacterial; Corticosteroid; Polymyxin-class Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482667010005followed by a unit qualifier and the quantityPackage 82667-0100-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indic…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 050023
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| neomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionOphthalmic | Nordic Pharma, Inc. | 69918-515 |