Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates and Hydrocortisone NDC 63187-308
neomycin sulfate, polymyxin b sulfate and hydrocortisone · Hydrocortisone 10 mg/mL + 2 more ingredients · Suspension/ drops · Auricular (Otic) · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-308-10 | 63187030810 | 1 BOTTLE, DROPPER in 1 CARTON (63187-308-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from May 2, 2016 |
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 and Polymyxin B Sulfates and Hydrocortisone
- Generic name (nonproprietary)
- neomycin sulfate, polymyxin b sulfate and hydrocortisone
- Active ingredients
- Hydrocortisone — 10 mg/mLNeomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [USP'U]/mL
- Dosage form
- Suspension/ drops
- Route
- Auricular (Otic)
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064065
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 63187-308_302d5baa-e97c-46cf-a72c-2c77b5a29b7eSPL ID 302d5baa-e97c-46cf-a72c-2c77b5a29b7eSPL set ID 98042cef-2839-49d6-a7bd-a1d29c74430bRxCUI 310687UNII WI4X0X7BPJ, 057Y626693, 19371312D4UPC 0363187308100
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N463187030810followed by a unit qualifier and the quantityPackage 63187-0308-10. 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)
INDlCATlONS AND USAGE For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 064065
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 Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Hydrocortisone 10 mg/mL + 2 more ingredients | Suspension/ dropsAuricular (Otic) | A-S Medication Solutions | 50090-0431 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Hydrocortisone 10 mg/mL + 2 more ingredients | Suspension/ dropsAuricular (Otic) | NuCare Pharmaceuticals,Inc. | 68071-4229 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Hydrocortisone 10 mg/mL + 2 more ingredients | Suspension/ dropsAuricular (Otic) | Bausch & Lomb Incorporated | 24208-635 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Hydrocortisone 10 mg/mL + 2 more ingredients | Suspension/ dropsAuricular (Otic) | Preferred Pharmaceuticals, Inc. | 68788-9924 |