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NDC 61314-0646-10 Neomycin and Polymyxin B Sulfates and Hydrocortisone 10; 3.5; 10000 mg/mL; mg/mL; [iU]/mL Details
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10; 3.5; 10000 mg/mL; mg/mL; [iU]/mL
Neomycin and Polymyxin B Sulfates and Hydrocortisone is a AURICULAR (OTIC) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc. The primary component is HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.
MedlinePlus Drug Summary
Neomycin, polymyxin, and hydrocortisone otic combination is used to treat outer ear infections caused by certain bacteria. It is also used to treat outer ear infections that can occur after certain types of ear surgery. Neomycin and polymyxin are in a class of medications called antibiotics. They work by stopping the growth of bacteria. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the ear to reduce swelling, redness, and itching.
Related Packages: 61314-0646-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Hydrocortisone Otic
Product Information
| NDC | 61314-0646 |
|---|---|
| Product ID | 61314-646_a3e39398-1292-491a-a063-4f9406be7dce |
| Associated GPIs | 87991003102010 |
| GCN Sequence Number | 048557 |
| GCN Sequence Number Description | neomycin/polymyxin B/hydrocort SOLUTION 3.5-10K-1 OTIC (EAR) |
| HIC3 | Q8W |
| HIC3 Description | EAR PREPARATIONS,ANTIBIOTICS |
| GCN | 14023 |
| HICL Sequence Number | 003368 |
| HICL Sequence Number Description | NEOMYCIN SULFATE/POLYMYXIN B SULFATE/HYDROCORTISONE |
| Brand/Generic | Generic |
| Proprietary Name | Neomycin and Polymyxin B Sulfates and Hydrocortisone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | neomycin sulfate, polymyxin b sulfate and hydrocortisone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | AURICULAR (OTIC) |
| Active Ingredient Strength | 10; 3.5; 10000 |
| Active Ingredient Units | mg/mL; mg/mL; [iU]/mL |
| Substance Name | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
| Labeler Name | Sandoz Inc |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA062423 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 61314-0646-10 (61314064610)
| NDC Package Code | 61314-646-10 |
|---|---|
| Billing NDC | 61314064610 |
| Package | 1 BOTTLE in 1 CARTON (61314-646-10) / 10 mL in 1 BOTTLE |
| Marketing Start Date | 2003-03-18 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 4.99457 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | NEOMYCIN-POLYMYXIN-HC EAR SOLN |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |