Prescription drug · ANDA
Neomycin Polymyxin B Sulfates And Dexamethasone NDC 72189-320
neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Suspension/ drops · Topical · DirectRx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-320-05 | 72189032005 | 5 mL in 1 BOTTLE (72189-320-05)Marketed from Jan 18, 2022 |
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)
- Neomycin Polymyxin B Sulfates And Dexamethasone
- Generic name (nonproprietary)
- neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops
- Active ingredients
- Neomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [USP'U]/mLDexamethasone — 1 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Topical
- Labeler
- DirectRx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064135
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 72189-320_32d607f3-fd60-9098-e063-6294a90a57afSPL ID 32d607f3-fd60-9098-e063-6294a90a57afSPL set ID d5e00bad-abb4-63ad-e053-2a95a90a5abbRxCUI 309680UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472189032005followed by a unit qualifier and the quantityPackage 72189-0320-05. 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)
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 indicated where the risk of…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 064135
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 Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-0570 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-830 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | Proficient Rx LP | 63187-498 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | Preferred Pharmaceuticals, Inc. | 68788-9702 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4375 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.