Prescription drug · ANDA
Neomycin Polymyxin B Sulfates and Dexamethasone NDC 63187-498
neomycin sulfate, polymyxin b sulfate and dexamethasone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Suspension/ drops · Ophthalmic · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-498-05 | 6318704980563187049805 | 1 BOTTLE, DROPPER in 1 CARTON (63187-498-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Feb 2, 2015 |
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
- Active ingredients
- Neomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [USP'U]/mLDexamethasone — 1 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Proficient Rx LPNDC labeler code 63187
- 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 63187-498_fe6c9c95-3714-4bc9-8de6-52e327ae3bbdSPL ID fe6c9c95-3714-4bc9-8de6-52e327ae3bbdSPL set ID 548089f3-29d8-4ba8-af21-9e04356ac29cRxCUI 309680UNII 057Y626693, 19371312D4, 7S5I7G3JQLUPC 0363187498054
- 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
N463187049805followed by a unit qualifier and the quantityPackage 63187-0498-05. 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 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 conjunctivitis 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 wher…
Excerpt only. Read the full label for complete information.
About NDC 63187-498
- What is NDC 63187-498?
- 63187-498 is the product NDC for Neomycin Polymyxin B Sulfates and Dexamethasone, Neomycin sulfate 3.5 mg/mL + 2 more ingredients suspension/ drops, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Neomycin Polymyxin B Sulfates and Dexamethasone (Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone).
- What is the active ingredient?
- Neomycin sulfate, Polymyxin b sulfate, Dexamethasone.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Neomycin Polymyxin B Sulfates and Dexamethasone?
- 5 other product NDCs are listed under this name. See all Neomycin Polymyxin B Sulfates and Dexamethasone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Neomycin Polymyxin B Sulfates and Dexamethasone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Neomycin Polymyxin B Sulfates And Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsTopical | DirectRx | 72189-320 | 72189-0320-05 |
| 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 | 68788-9702-05 |
| 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 | 24208-0830-60 |
| 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 | 50090-0570-00 |
| 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 | 68071-4375-05 |
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 | 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 | 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 | NuCare Pharmaceuticals,Inc. | 68071-4375 |
| 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 suspension/ drops | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsTopical | DirectRx | 72189-320 |