Search by Drug Name or NDC
NDC 63629-8716-01 Ofloxacin Otic 3 mg/mL Details
Ofloxacin Otic 3 mg/mL
Ofloxacin Otic is a AURICULAR (OTIC) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is OFLOXACIN.
MedlinePlus Drug Summary
Ofloxacin otic is used to treat outer ear infections in adults and children, chronic (long-lasting) middle ear infections in adults and children with a perforated eardrum (a condition where the eardrum has a hole in it), and acute (suddenly occurring) middle ear infections in children with ear tubes. Ofloxacin otic is in a class of medications called quinolone antibiotics. It works by killing the bacteria that cause infection.
Related Packages: 63629-8716-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ofloxacin Otic
Product Information
| NDC | 63629-8716 |
|---|---|
| Product ID | 63629-8716_7dcf4ee7-c1d6-4608-b182-d408e8c4bfef |
| Associated GPIs | 87100060002010 |
| GCN Sequence Number | 048292 |
| GCN Sequence Number Description | ofloxacin DROPS 0.3 % OTIC (EAR) |
| HIC3 | Q8W |
| HIC3 Description | EAR PREPARATIONS,ANTIBIOTICS |
| GCN | 13880 |
| HICL Sequence Number | 006035 |
| HICL Sequence Number Description | OFLOXACIN |
| Brand/Generic | Generic |
| Proprietary Name | Ofloxacin Otic |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ofloxacin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | AURICULAR (OTIC) |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/mL |
| Substance Name | OFLOXACIN |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Quinolone Antimicrobial [EPC], Quinolones [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076527 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-8716-01 (63629871601)
| NDC Package Code | 63629-8716-1 |
|---|---|
| Billing NDC | 63629871601 |
| Package | 5 mL in 1 BOTTLE, DROPPER (63629-8716-1) |
| Marketing Start Date | 2021-08-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |