Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates and Hydrocortisone NDC 50090-0431
neomycin sulfate, polymyxin b sulfate and hydrocortisone · Hydrocortisone 10 mg/mL + 2 more ingredients · Suspension/ drops · Auricular (Otic) · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0431-0 | 50090043100 | 1 BOTTLE, DROPPER in 1 CARTON (50090-0431-0) / 10 mL in 1 BOTTLE, DROPPERMarketed from Jun 29, 2016 |
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 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
- A-S Medication Solutions
- 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 50090-0431_29d9c79c-f605-4755-996a-7dc78ecb89e7SPL ID 29d9c79c-f605-4755-996a-7dc78ecb89e7SPL set ID 1185a82b-e731-456a-8fc1-d9f0fc1ab0bcRxCUI 310687UNII WI4X0X7BPJ, 057Y626693, 19371312D4
- 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
N450090043100followed by a unit qualifier and the quantityPackage 50090-0431-00. 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 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) | 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) | Proficient Rx LP | 63187-308 |
| 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 |