NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6336Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6336Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50090-6336-0500906336001 BOTTLE in 1 CARTON (50090-6336-0) / 10 mL in 1 BOTTLEMarketed from Jan 18, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
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 50090-6336_bf72b106-e8dc-4f1b-bc67-aa6c6f89ed9aSPL ID bf72b106-e8dc-4f1b-bc67-aa6c6f89ed9aSPL set ID c895676f-446a-4a93-a3d2-addcce96b108RxCUI 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

N450090633600 followed by a unit qualifier and the quantity

Package 50090-6336-00. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 060613

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 060613
ProductStrengthForm · routeLabelerProduct NDC
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin b sulfates and hydrocortisone oticHydrocortisone 10 mg/mL + 2 more ingredientsSuspensionAuricular (Otic)Preferred Pharmaceuticals, Inc.68788-7787
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin b sulfates and hydrocortisone oticHydrocortisone 10 mg/mL + 2 more ingredientsSuspensionAuricular (Otic)Rising Pharma Holdings, Inc.64980-448

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