Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates and Hydrocortisone NDC 61314-641
neomycin sulfate, polymyxin b sulfate and hydrocortisone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Suspension · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-641-75 | 6131406417561314064175 | 7.5 mL in 1 BOTTLE, PLASTIC (61314-641-75)Marketed from May 9, 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
- Ophthalmic
- Labeler
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062874
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 61314-641_15cc1b8f-5a7f-4cfb-8c65-9d35f7c0f30fSPL ID 15cc1b8f-5a7f-4cfb-8c65-9d35f7c0f30fSPL set ID 96a7b0a5-030a-42dc-80cd-35c4e9aa1b6dRxCUI 204874UNII 057Y626693, 19371312D4, WI4X0X7BPJUPC 0361314641755
- 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 HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461314064175followed by a unit qualifier and the quantityPackage 61314-0641-75. 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 Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetrat…
Excerpt only. Read the full label for complete information.
About NDC 61314-641
- What is NDC 61314-641?
- 61314-641 is the product NDC for Neomycin and Polymyxin B Sulfates and Hydrocortisone, Neomycin sulfate 3.5 mg/mL + 2 more ingredients suspension, 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 | SolutionAuricular (Otic) | Sandoz Inc | 61314-646 | 61314-0646-10 |
| 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