Prescription drug · ANDA
Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC NDC 81607-014
neomycin and polymyxin b sulfates and hydrocortisone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Solution/ drops · Auricular (Otic) · Orbicular Pharmaceutical Technologies Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81607-014-10 | 8160700141081607001410 | 1 BOTTLE, DROPPER in 1 CARTON (81607-014-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 8, 2026 |
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 OTICSuffix: OTIC
- Generic name (nonproprietary)
- neomycin and polymyxin b sulfates and hydrocortisone
- Active ingredients
- Neomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [iU]/mLHydrocortisone — 10 mg/mL
- Dosage form
- Solution/ drops
- Route
- Auricular (Otic)
- Labeler
- Orbicular Pharmaceutical Technologies Private LimitedNDC labeler code 81607
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220938
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 81607-014_d432f97b-7f75-4a04-96a7-de9c9124824cSPL ID d432f97b-7f75-4a04-96a7-de9c9124824cSPL set ID 5eae31aa-ec63-4b93-9859-8d718a8ac8efRxCUI 204423UNII 057Y626693, 19371312D4, WI4X0X7BPJUPC 0381607014103
- 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
N481607001410followed by a unit qualifier and the quantityPackage 81607-0014-10. 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 81607-014
- What is NDC 81607-014?
- 81607-014 is the product NDC for Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC, Neomycin sulfate 3.5 mg/mL + 2 more ingredients solution/ drops, listed with the FDA by Orbicular Pharmaceutical Technologies Private Limited. 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 (Neomycin and Polymyxin B sulfates and Hydrocortisone).
- What is the active ingredient?
- Neomycin sulfate, Polymyxin b sulfate, Hydrocortisone.
- Who is the labeler?
- Orbicular Pharmaceutical Technologies Private Limited, NDC labeler code 81607. 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?
- None: this is the only finished product listed under this name.
- 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 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 OTICneomycin and polymyxin b sulfates and hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Solution/ dropsAuricular (Otic) | Hikma Pharmaceuticals USA Inc. | 0054-0975 | 00054-0975-80 |
Other NDCs under ANDA 220938
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 OTICneomycin and polymyxin b sulfates and hydrocortisone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Solution/ dropsAuricular (Otic) | Hikma Pharmaceuticals USA Inc. | 0054-0975 |