Prescription drug · ANDA
Ciprofloxacin and dexamethasone NDC 62756-427
Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL · Suspension/ drops · Auricular (Otic) · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-427-90 | 6275604279062756042790 | 1 BOTTLE, DROPPER in 1 CARTON (62756-427-90) / 7.5 mL in 1 BOTTLE, DROPPERMarketed from Sep 1, 2022 |
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
- Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210470
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 62756-427_4ba06043-b13f-42fe-a398-fe7e7b84163eSPL ID 4ba06043-b13f-42fe-a398-fe7e7b84163eSPL set ID 641bad60-9b9e-43ea-936e-5c38f27835b2RxCUI 403908UNII 4BA73M5E37, 7S5I7G3JQLUPC 0362756427907
- 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
N462756042790followed by a unit qualifier and the quantityPackage 62756-0427-90. 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, USP 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 and …
Excerpt only. Read the full label for complete information.
About NDC 62756-427
- What is NDC 62756-427?
- 62756-427 is the product NDC for Ciprofloxacin and dexamethasone, Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL suspension/ drops, listed with the FDA by Sun Pharmaceutical Industries, 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. 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.
Related NDCs: other Ciprofloxacin and dexamethasone products
Other finished products listed under the same name: strengths, forms and labelers.
| 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) | Amneal Pharmaceuticals of New York LLC | 53746-831 | 53746-0831-53 |
| 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) | 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 |
Other NDCs under ANDA 210470
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 |
|---|---|---|---|---|
| Ciprofloxacin and dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | NuCare Pharmaceutical, Inc. | 68071-3977 |