Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates and Hydrocortisone NDC 61314-646
neomycin sulfate, polymyxin b sulfate and hydrocortisone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Solution · Auricular (Otic) · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-646-10 | 6131406461061314064610 | 1 BOTTLE in 1 CARTON (61314-646-10) / 10 mL in 1 BOTTLEMarketed from Mar 18, 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 [iU]/mLHydrocortisone — 10 mg/mL
- Dosage form
- Solution
- Route
- Auricular (Otic)
- Labeler
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062423
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 61314-646_2a1e7a16-dc94-4cf1-b01f-89e1d7355170SPL ID 2a1e7a16-dc94-4cf1-b01f-89e1d7355170SPL set ID ff34da77-5e96-4ed1-8c28-ba0b2f35576aRxCUI 204423UNII 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
N461314064610followed by a unit qualifier and the quantityPackage 61314-0646-10. 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)
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.
Excerpt only. Read the full label for complete information.
About NDC 61314-646
- What is NDC 61314-646?
- 61314-646 is the product NDC for Neomycin and Polymyxin B Sulfates and Hydrocortisone, Neomycin sulfate 3.5 mg/mL + 2 more ingredients solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Neomycin and Polymyxin B Sulfates and Hydrocortisone (Neomycin sulfate, polymyxin b sulfate and hydrocortisone).
- What is the active ingredient?
- Neomycin sulfate, Polymyxin b sulfate, Hydrocortisone.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Neomycin and Polymyxin B Sulfates and Hydrocortisone?
- 21 other product NDCs are listed under this name. See all Neomycin and Polymyxin B Sulfates and Hydrocortisone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Neomycin and Polymyxin B Sulfates and Hydrocortisone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Neomycin And Polymyxin B Sulfates And Hydrocortisoneneomycin sulfate, polymyxin b sulfate, hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Solution/ dropsAuricular (Otic) | Amneal Pharmaceuticals NY LLC | 60219-2083 | 60219-2083-01 |
| Neomycin And Polymyxin B Sulfates And Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Hydrocortisone 10 mg/mL + 2 more ingredients | Suspension/ dropsAuricular (Otic) | Amneal Pharmaceuticals NY LLC | 60219-2084 | 60219-2084-06 |
| 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 | 68788-8130-01 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate, hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Solution/ dropsAuricular (Otic) | REMEDYREPACK INC. | 70518-0763 | 70518-0763-00 |
| 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 | 68788-9924-01 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionOphthalmic | Sandoz Inc | 61314-641 | 61314-0641-75 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SolutionAuricular (Otic) | Proficient Rx LP | 63187-568 | 63187-0568-10 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionAuricular (Otic) | A-S Medication Solutions | 50090-2365 | 50090-2365-00 |
| 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 | 61314-0645-11 |
| 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 | 63187-0648-10 |
All 22 Neomycin and Polymyxin B Sulfates and Hydrocortisone NDCs
Other NDCs under ANDA 062423
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 | SolutionAuricular (Otic) | Proficient Rx LP | 63187-568 |