Prescription drug · NDA AUTHORIZED GENERIC
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension NDC 64980-448
neomycin and polymyxin b sulfates and hydrocortisone otic · Hydrocortisone 10 mg/mL + 2 more ingredients · Suspension · Auricular (Otic) · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-448-01 | 6498004480164980044801 | 1 BOTTLE in 1 CARTON (64980-448-01) / 10 mL in 1 BOTTLEMarketed from Mar 15, 2019 |
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 Otic Suspension
- Generic name (nonproprietary)
- neomycin and polymyxin b sulfates and hydrocortisone otic
- Active ingredients
- Hydrocortisone — 10 mg/mLNeomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [USP'U]/mL
- Dosage form
- Suspension
- Route
- Auricular (Otic)
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 060613
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 64980-448_4b15047c-4c19-4562-ba03-5c1aff192a2fSPL ID 4b15047c-4c19-4562-ba03-5c1aff192a2fSPL set ID 35768adc-b578-4c2e-b461-22de3135a789RxCUI 310687UNII WI4X0X7BPJ, 057Y626693, 19371312D4
- 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
N464980044801followed by a unit qualifier and the quantityPackage 64980-0448-01. 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.
About NDC 64980-448
- What is NDC 64980-448?
- 64980-448 is the product NDC for Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, Hydrocortisone 10 mg/mL + 2 more ingredients suspension, listed with the FDA by Rising Pharma Holdings, 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 Otic Suspension (Neomycin and polymyxin B sulfates and hydrocortisone otic).
- What is the active ingredient?
- Hydrocortisone, Neomycin sulfate, Polymyxin b sulfate.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 Otic Suspension?
- 2 other product NDCs are listed under this name. See all Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 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 Otic Suspension 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 Hydrocortisone Otic Suspensionneomycin and polymyxin b sulfates and hydrocortisone otic | Hydrocortisone 10 mg/mL + 2 more ingredients | SuspensionAuricular (Otic) | Preferred Pharmaceuticals, Inc. | 68788-7787 | 68788-7787-01 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin b sulfates and hydrocortisone otic | Hydrocortisone 10 mg/mL + 2 more ingredients | SuspensionAuricular (Otic) | A-S Medication Solutions | 50090-6336 | 50090-6336-00 |
Other NDCs under NDA 060613
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 Hydrocortisone Otic Suspensionneomycin and polymyxin b sulfates and hydrocortisone otic | Hydrocortisone 10 mg/mL + 2 more ingredients | SuspensionAuricular (Otic) | A-S Medication Solutions | 50090-6336 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin b sulfates and hydrocortisone otic | Hydrocortisone 10 mg/mL + 2 more ingredients | SuspensionAuricular (Otic) | Preferred Pharmaceuticals, Inc. | 68788-7787 |