Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates and Dexamethasone NDC 68788-8748
neomycin sulfate, polymyxin b sulfate, and dexamethasone · Neomycin sulfate 3.5 mg/g + 2 more ingredients · Ointment · Ophthalmic · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8748-3 | 68788874803 | 1 TUBE in 1 CARTON (68788-8748-3) / 3.5 g in 1 TUBEMarketed from Oct 11, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Neomycin and Polymyxin B Sulfates and Dexamethasone
- 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064063
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 68788-8748_eb89e778-f8f3-40f2-9506-62f00128ad08SPL ID eb89e778-f8f3-40f2-9506-62f00128ad08SPL set ID e42d4837-77c2-40c3-8705-20966a51a822RxCUI 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
N468788874803followed by a unit qualifier and the quantityPackage 68788-8748-03. 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.
Other NDCs under ANDA 064063
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 and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Proficient Rx LP | 63187-669 |
| Neomycin And Polymyxin B Sulfates And Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0229 |
| Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Bausch & Lomb Incorporated | 24208-795 |
| Neo/Poly-B/Dex Ophth Oint | Polymyxin b sulfate 10000 [USP'U]/g + 2 more ingredients | OintmentOphthalmic | Direct_Rx | 72189-532 |
| Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | A-S Medication Solutions | 50090-6181 |
| Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-2428 |