Levofloxacin
- Product NDC
- 17478-106
- 11-digit product format
- 174780106
- Labeler code
- 17478
- Product ID
- 17478-106_c95440ae-7fb1-4878-bdcd-132029d1d207
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA090268
- Marketing category
- ANDA
- Marketing start
- 2011-03-01
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17478-106-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0579-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use LEVOFLOXACIN OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for LEVOFLOXACIN OPHTHALMIC SOLUTION. LEVOFLOXACIN ophthalmic solution, for topical application in the eye Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17478-106-10 | Levofloxacin | 1 in 1 CARTON | SOLUTION | 1 | 7 | |
| 17478-106-10 | Levofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-106-10 | ML - Milliliter | 17478-106 | 4751da93-ebf1-4294-acb9-2b8aece4cf64 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| levofloxacin | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN SOLUTION [AKORN INC.] | 2 | |
| levofloxacin | ACTIVE MOIETY | 6GNT3Y5LMF | LEVOFLOXACIN SOLUTION [AKORN INC.] | 2 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | LEVOFLOXACIN SOLUTION [AKORN INC.] | 2 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | LEVOFLOXACIN SOLUTION [AKORN INC.] | 2 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | LEVOFLOXACIN SOLUTION [AKORN INC.] | 2 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | LEVOFLOXACIN SOLUTION [AKORN INC.] | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | LEVOFLOXACIN SOLUTION [AKORN INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314080 | levoFLOXacin 0.5 % Ophthalmic Solution | PSN | 6987500a-2feb-48a9-9d29-89693333a801 | 7 |
| 314080 | levofloxacin 5 MG/ML Ophthalmic Solution | SCD | 6987500a-2feb-48a9-9d29-89693333a801 | 7 |
| 314080 | levofloxacin 0.5 % Ophthalmic Solution | SY | 6987500a-2feb-48a9-9d29-89693333a801 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17478-106-10 | 17478010610 | 1 BOTTLE, DROPPER in 1 CARTON (17478-106-10) > 5 mL in 1 BOTTLE, DROPPER | 2011-03-01 | 0000-00-00 | No | No | Current |