NDC codes

FDA NDC Directory
Product NDC (as listed)67296-2257Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-2257Add 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
67296-2257-8672962257081 BOTTLE, DROPPER in 1 CARTON (67296-2257-8) / 7.5 mL in 1 BOTTLE, DROPPERMarketed from Aug 1, 2022

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)
Ciprofloxacin and Dexamethasone
Generic name (nonproprietary)
ciprofloxacin and dexamethasone
Active ingredients
Ciprofloxacin hydrochloride — 3 mg/mLDexamethasone — 1 mg/mL
Dosage form
Suspension/ drops
Route
Auricular (Otic)
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205548
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers
Product ID 67296-2257_546c14eb-f8b7-f4a4-e063-6394a90af458SPL ID 546c14eb-f8b7-f4a4-e063-6394a90af458SPL set ID 546bf602-4b4c-cb08-e063-6394a90a2c55RxCUI 403908UNII 4BA73M5E37, 7S5I7G3JQLUPC 0316714628011

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

N467296225708 followed by a unit qualifier and the quantity

Package 67296-2257-08. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 205548

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

FDA NDC Directory listings under ANDA 205548
ProductStrengthForm · routeLabelerProduct NDC
Ciprofloxacin and DexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)Dr. Reddy's Laboratories, Inc.43598-326
Ciprofloxacin and DexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)Sportpharm LLC85766-245
Ciprofloxacin and DexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)NuCare Pharmaceuticals, Inc.68071-3804
Ciprofloxacin and DexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)NorthStar RxLLC16714-628

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