Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates and Hydrocortisone NDC 61314-645
neomycin sulfate, polymyxin b sulfate and hydrocortisone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Suspension · Auricular (Otic) · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-645-11 | 61314064511 | 10 mL in 1 BOTTLE, PLASTIC (61314-645-11)Marketed from Mar 17, 2003 |
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
- Neomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [USP'U]/mLHydrocortisone — 10 mg/mL
- Dosage form
- Suspension
- Route
- Auricular (Otic)
- Labeler
- Sandoz Inc.
- 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 61314-645_99d0c7c1-3bf0-4491-b093-551555f7e80cSPL ID 99d0c7c1-3bf0-4491-b093-551555f7e80cSPL set ID 99d9030f-9118-412c-a377-d1df1c8fa723RxCUI 310687UNII 057Y626693, 19371312D4, WI4X0X7BPJUPC 0361314645111
- 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
N461314064511followed by a unit qualifier and the quantityPackage 61314-0645-11. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.