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NDC 53002-1350-01 Levofloxacin 500 mg/1 Details
Levofloxacin 500 mg/1
Levofloxacin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is LEVOFLOXACIN.
MedlinePlus Drug Summary
Levofloxacin is used to treat certain infections such as pneumonia, and kidney, prostate (a male reproductive gland), and skin infections. Levofloxacin is also used to prevent anthrax (a serious infection that may be spread on purpose as part of a bioterror attack) in people who may have been exposed to anthrax germs in the air, and treat and prevent plague (a serious infection that may be spread on purpose as part of a bioterror attack. Levofloxacin may also be used to treat bronchitis, sinus infections, or urinary tract infections but should not be used for bronchitis and certain types of urinary tract infections if there are other treatment options available. Levofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics such as levofloxacin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 53002-1350-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levofloxacin
Product Information
| NDC | 53002-1350 |
|---|---|
| Product ID | 53002-1350_fccd14cb-70f1-4916-8ff6-bce97c5955f2 |
| Associated GPIs | |
| 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 | Levofloxacin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Levofloxacin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | LEVOFLOXACIN |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202801 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1350-01 (53002135001)
| NDC Package Code | 53002-1350-1 |
|---|---|
| Billing NDC | 53002135001 |
| Package | 10 TABLET, FILM COATED in 1 BOTTLE (53002-1350-1) |
| Marketing Start Date | 2017-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |