Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates and Hydrocortisone NDC 50090-2365
neomycin sulfate, polymyxin b sulfate and hydrocortisone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Suspension · Auricular (Otic) · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-2365-0 | 50090236500 | 10 mL in 1 BOTTLE, PLASTIC (50090-2365-0)Marketed from Apr 22, 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
- Neomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [USP'U]/mLHydrocortisone — 10 mg/mL
- Dosage form
- Suspension
- Route
- Auricular (Otic)
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062488
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 50090-2365_711c99fe-2737-4c5e-9b16-93d10d2b1115SPL ID 711c99fe-2737-4c5e-9b16-93d10d2b1115SPL set ID 84d32193-c2cc-4837-88d1-c7d7dc2c7042RxCUI 310687UNII 057Y626693, 19371312D4, WI4X0X7BPJ
- 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
N450090236500followed by a unit qualifier and the quantityPackage 50090-2365-00. 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 062488
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 | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionAuricular (Otic) | Preferred Pharmaceuticals Inc. | 68788-8130 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionAuricular (Otic) | Proficient Rx LP | 63187-648 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionAuricular (Otic) | Bryant Ranch Prepack | 63629-8844 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionAuricular (Otic) | Sandoz Inc. | 61314-645 |