Prescription drug · NDA
Maxitrol NDC 66758-070
neomycin sulfate, polymyxin b sulfate and dexamethasone · Neomycin sulfate 3.5 mg/g + 2 more ingredients · Ointment · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66758-070-38 | 6675800703866758007038 | 3.5 g in 1 TUBE (66758-070-38)Marketed from Sep 2, 2024 |
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/gPolymyxin b sulfate — 10000 [USP'U]/gDexamethasone — 1 mg/g
- Dosage form
- Ointment
- Route
- Ophthalmic
- Labeler
- Sandoz IncNDC labeler code 66758
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050065
- Marketing start
- Marketing end
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 66758-070_67c1198f-4925-4e0f-a788-bbdf86abedebSPL ID 67c1198f-4925-4e0f-a788-bbdf86abedebSPL set ID 5776c435-ac60-49b6-8db1-23a3012b9155RxCUI 208601, 309679UNII 057Y626693, 19371312D4, 7S5I7G3JQL
- 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
N466758007038followed by a unit qualifier and the quantityPackage 66758-0070-38. 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 ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid 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 indicated whe…
Excerpt only. Read the full label for complete information.
About NDC 66758-070
- What is NDC 66758-070?
- 66758-070 is the product NDC for Maxitrol, Neomycin sulfate 3.5 mg/g + 2 more ingredients ointment, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Maxitrol (Neomycin sulfate, polymyxin b sulfate and dexamethasone).
- What is the active ingredient?
- Neomycin sulfate, Polymyxin b sulfate, Dexamethasone.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 66758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Maxitrol?
- 2 other product NDCs are listed under this name. See all Maxitrol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Maxitrol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Maxitrolneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Novartis Pharmaceuticals Corporation | 0078-0771 | 00078-0771-01 |
| Maxitrolneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionOphthalmic | Harrow Eye, LLC | 82667-100 | 82667-0100-05 |
Other NDCs under NDA 050065
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 |
|---|---|---|---|---|
| Maxitrolneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Novartis Pharmaceuticals Corporation | 0078-0771 |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | A-S Medication Solutions | 50090-4435 |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Sandoz Inc | 61314-631 |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-5281 |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Proficient Rx LP | 71205-330 |