Levofloxacin
- Product NDC
- 36000-045
- 11-digit product format
- 360000045
- Labeler code
- 36000
- Product ID
- 36000-045_3cbc7b81-fabf-4666-951c-76f19e4f3222
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levofloxacin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA091436
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- Substance
- LEVOFLOXACIN
- Active strength
- 25 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levofloxacin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOFLOXACIN | 25 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 1665497, 1665507, 1665515, 1665517 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| addb5519-f7ae-4d4e-b9ca-f782a1597fd3 | Product name | 2 | 20210610 |
| fb758c6a-fdee-40a8-99c2-46f79c3ff90c | Product name | 4 | 20200807 |
| 1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6d | Product name | 1 | 20190618 |
| aea4a616-4dfe-45f6-94bb-8b9063056ceb | Product name | 6 | 20190611 |
| 2246ce8e-a477-4dc3-b6d6-fe9973c18ed1 | Product name | 1 | 20180821 |
| 5a6c788d-375b-4565-a8ae-67c179a30c93 | Product name | 1 | 20180212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36000-045-01 | Levofloxacin | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 20 | 27 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.] | 9 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.] | 9 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.] | 9 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.] | 9 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.] | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1665497 | levoFLOXacin 250 MG in 50 ML Injection | PSN | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665507 | levoFLOXacin 500 MG in 100 ML Injection | PSN | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665517 | levoFLOXacin 500 MG in 20 ML Injection | PSN | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665515 | levoFLOXacin 750 MG in 150 ML Injection | PSN | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665507 | 100 ML levofloxacin 5 MG/ML Injection | SCD | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665515 | 150 ML levofloxacin 5 MG/ML Injection | SCD | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665517 | 20 ML levofloxacin 25 MG/ML Injection | SCD | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665497 | 50 ML levofloxacin 5 MG/ML Injection | SCD | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665497 | levofloxacin 250 MG per 50 ML Injection | SY | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665507 | levofloxacin 500 MG per 100 ML Injection | SY | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665517 | levofloxacin 500 MG per 20 ML Injection | SY | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
| 1665515 | levofloxacin 750 MG per 150 ML Injection | SY | 70c87464-1806-480a-8ebd-3f02987ff436 | 27 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36000-045-01 | 36000004501 | 20 mL in 1 VIAL, SINGLE-USE (36000-045-01) | 20 ml | 2013-07-01 | 0000-00-00 | No | No | Current |