Prescription drug · ANDA
Ofloxacin Otic (Ofloxacin) NDC 68071-1630
Ofloxacin 3 mg/mL · Solution · Auricular (Otic) · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-1630-3 | 6807116300368071163003 | 10 mL in 1 BOTTLE (68071-1630-3)Marketed from Sep 28, 2018 |
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)
- Ofloxacin Otic
- Generic name (nonproprietary)
- ofloxacin
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution
- Route
- Auricular (Otic)
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076527
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 68071-1630_2a2f62dc-8ba6-7ca9-e063-6294a90aca76SPL ID 2a2f62dc-8ba6-7ca9-e063-6294a90aca76SPL set ID 76f461da-0e15-aa6d-e053-2a91aa0a9808RxCUI 242446UNII A4P49JAZ9HUPC 0368071163032
- Pharmacologic class
- Quinolone Antimicrobial
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
N468071163003followed by a unit qualifier and the quantityPackage 68071-1630-03. 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 Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis , Pseudomonas aeruginosa, and Staphylococcus aureus . Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis , Pseudomonas aeruginosa, Staphylococcu…
Excerpt only. Read the full label for complete information.
About NDC 68071-1630
- What is NDC 68071-1630?
- 68071-1630 is the product NDC for Ofloxacin Otic (ofloxacin), Ofloxacin 3 mg/mL solution, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ofloxacin Otic (Ofloxacin).
- What is the active ingredient?
- Ofloxacin.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ofloxacin Otic?
- 9 other product NDCs are listed under this name. See all Ofloxacin Otic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ofloxacin Otic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | REMEDYREPACK INC. | 70518-4226 | 70518-4226-00 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | DIRECT RX | 72189-108 | 72189-0108-05 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | A-S Medication Solutions | 50090-1090 | 50090-1090-00 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Apotex Corp. | 60505-0363 | 60505-0363-0160505-0363-02 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Proficient Rx LP | 63187-184 | 63187-0184-05 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 63629-8716 | 63629-8716-01 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | NuCare Pharmaceuticals,Inc. | 68071-1588 | 68071-1588-05 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 71335-2822 | 71335-2822-01 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 72162-1709 | 72162-1709-02 |
Other NDCs under ANDA 076527
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 |
|---|---|---|---|---|
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | A-S Medication Solutions | 50090-1090 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Apotex Corp. | 60505-0363 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Proficient Rx LP | 63187-184 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 63629-8716 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | NuCare Pharmaceuticals,Inc. | 68071-1588 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | REMEDYREPACK INC. | 70518-4226 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 71335-2822 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 72162-1709 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | DIRECT RX | 72189-108 |