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NDC 53002-1604-01 Ofloxacin 3 mg/mL Details
Ofloxacin 3 mg/mL
Ofloxacin is a AURICULAR (OTIC) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. 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: 53002-1604-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ofloxacin Otic
Product Information
| NDC | 53002-1604 |
|---|---|
| Product ID | 53002-1604_42ee1ff7-4404-42b5-be60-8766c7df262b |
| Associated GPIs | 87100060002010 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Ofloxacin |
| 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 | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | Quinolone Antimicrobial [EPC], Quinolones [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076128 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1604-01 (53002160401)
| NDC Package Code | 53002-1604-1 |
|---|---|
| Billing NDC | 53002160401 |
| Package | 5 mL in 1 BOTTLE, DROPPER (53002-1604-1) |
| Marketing Start Date | 2017-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |