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NDC 63323-0355-65 Levofloxacin 5 mg/mL Details
Levofloxacin 5 mg/mL
Levofloxacin is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is LEVOFLOXACIN.
MedlinePlus Drug Summary
Levofloxacin injection is used to treat infections such as pneumonia; and kidney, prostate (a male reproductive gland), and skin infections. Levofloxacin injection 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 injection is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics such as levofloxacin injection 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: 63323-0355-65Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levofloxacin Injection
Product Information
| NDC | 63323-0355 |
|---|---|
| Product ID | 63323-355_7e3e7975-82d6-4394-847b-10deb1f97992 |
| Associated GPIs | 05000034112024 05000034112032 05000034112028 |
| GCN Sequence Number | 029925 |
| GCN Sequence Number Description | levofloxacin in dextrose 5 % PIGGYBACK 250MG/50ML INTRAVEN |
| HIC3 | W1Q |
| HIC3 Description | QUINOLONE ANTIBIOTICS |
| GCN | 47072 |
| HICL Sequence Number | 012383 |
| HICL Sequence Number Description | LEVOFLOXACIN/DEXTROSE 5 % IN WATER |
| Brand/Generic | Generic |
| Proprietary Name | Levofloxacin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LEVOFLOXACIN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | LEVOFLOXACIN |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA200674 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0355-65 (63323035565)
| NDC Package Code | 63323-355-65 |
|---|---|
| Billing NDC | 63323035565 |
| Package | 1 BAG in 1 POUCH (63323-355-65) / 100 mL in 1 BAG |
| Marketing Start Date | 2013-06-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |