What is NDC 53746-831?

53746-831 is the product NDC for Ciprofloxacin and Dexamethasone, Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL suspension/ drops, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Ciprofloxacin hydrochloride, Dexamethasone.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ciprofloxacin and Dexamethasone?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ciprofloxacin and Dexamethasone NDC 53746-831

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-831Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0831Add 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 NDC	11-digit (billing)	Package	Copy
53746-831-53	5374608315353746083153	1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53) / 7.5 mL in 1 BOTTLE, PLASTICMarketed from Mar 26, 2024

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): 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)
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216501
Marketing start: Mar 26, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers: Product ID 53746-831_718cd533-d887-4ef1-a7d0-fca696242bb2SPL ID 718cd533-d887-4ef1-a7d0-fca696242bb2SPL set ID 55426495-5fd1-44ca-afcc-ffbbb0a0a569RxCUI 403908UNII 4BA73M5E37, 7S5I7G3JQL
Pharmacologic class: Corticosteroid; Fluoroquinolone 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

N453746083153 followed by a unit qualifier and the quantity

Package 53746-0831-53. 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 Oct 26, 2022.

Indications (excerpt from the label)

Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. Ciprofloxacin and dexamethasone otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-831

What is NDC 53746-831?: 53746-831 is the product NDC for Ciprofloxacin and Dexamethasone, Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL suspension/ drops, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ciprofloxacin and Dexamethasone.
What is the active ingredient?: Ciprofloxacin hydrochloride, Dexamethasone.
Who is the labeler?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ciprofloxacin and Dexamethasone?: 12 other product NDCs are listed under this name. See all Ciprofloxacin and Dexamethasone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ciprofloxacin and Dexamethasone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ciprofloxacin and dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsAuricular (Otic)	Sentiss Pharmaceuticals LLC	70244-033	70244-0033-01
Ciprofloxacin and Dexamethasoneciprofloxacin hydrochloride and dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	SuspensionAuricular (Otic)	Upsher-Smith Laboratories, LLC	0832-1430	00832-1430-75
Ciprofloxacin and dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsAuricular (Otic)	Redpharm Drug	67296-1943	67296-1943-08
Ciprofloxacin and dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsAuricular (Otic)	ARMAS PHARMACEUTICALS INC.	72485-625	72485-0625-13
Ciprofloxacin and dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsAuricular (Otic)	Sun Pharmaceutical Industries, Inc.	62756-427	62756-0427-90
Ciprofloxacin and dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsAuricular (Otic)	NuCare Pharmaceutical, Inc.	68071-3977	68071-3977-07
Ciprofloxacin and Dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsAuricular (Otic)	NorthStar RxLLC	16714-628	16714-0628-01
Ciprofloxacin and Dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsAuricular (Otic)	Redpharm Drug	67296-2257	67296-2257-08
Ciprofloxacin and Dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsAuricular (Otic)	Sandoz Inc	0781-6186	00781-6186-67
Ciprofloxacin and Dexamethasone	Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsAuricular (Otic)	Dr. Reddy's Laboratories, Inc.	43598-326	43598-0326-75

All 13 Ciprofloxacin and Dexamethasone NDCs