NDC codes

FDA NDC Directory
Product NDC (as listed)0781-6186Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-6186Add 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
0781-6186-6700781618667007816186671 BOTTLE, DROPPER in 1 CARTON (0781-6186-67) / 7.5 mL in 1 BOTTLE, DROPPERMarketed from Aug 10, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021537
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers
Product ID 0781-6186_39a8b845-aa32-4c9d-bef8-18cea1ef7bc9SPL ID 39a8b845-aa32-4c9d-bef8-18cea1ef7bc9SPL set ID 89fef4d2-7078-47f1-96bf-aca50b135a97RxCUI 403908UNII 4BA73M5E37, 7S5I7G3JQLUPC 0307816186677

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

N400781618667 followed by a unit qualifier and the quantity

Package 00781-6186-67. 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)

Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: • Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus , Streptococcus pneumoniae , Haemophilus influenzae , Moraxella catarrhalis , and Pseudomonas aeruginosa . • 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-6186

What is NDC 0781-6186?
0781-6186 is the product NDC for Ciprofloxacin and Dexamethasone, Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL suspension/ drops, listed with the FDA by Sandoz Inc. 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?
Sandoz Inc, NDC labeler code 0781. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ciprofloxacin and dexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)Sentiss Pharmaceuticals LLC70244-03370244-0033-01
Ciprofloxacin and Dexamethasoneciprofloxacin hydrochloride and dexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspensionAuricular (Otic)Upsher-Smith Laboratories, LLC0832-143000832-1430-75
Ciprofloxacin and DexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)Amneal Pharmaceuticals of New York LLC53746-83153746-0831-53
Ciprofloxacin and dexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)Redpharm Drug67296-194367296-1943-08
Ciprofloxacin and dexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)ARMAS PHARMACEUTICALS INC.72485-62572485-0625-13
Ciprofloxacin and dexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)Sun Pharmaceutical Industries, Inc.62756-42762756-0427-90
Ciprofloxacin and dexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)NuCare Pharmaceutical, Inc.68071-397768071-3977-07
Ciprofloxacin and DexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)NorthStar RxLLC16714-62816714-0628-01
Ciprofloxacin and DexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)Redpharm Drug67296-225767296-2257-08
Ciprofloxacin and DexamethasoneCiprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsAuricular (Otic)Dr. Reddy's Laboratories, Inc.43598-32643598-0326-75

All 13 Ciprofloxacin and Dexamethasone NDCs

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