Ofloxacin
- Product NDC
- 50383-025
- 11-digit product format
- 503830025
- Labeler code
- 50383
- Product ID
- 50383-025_7aea230d-7672-4201-830b-7068863f3cee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxaxin
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Akorn
- Application
- ANDA076616
- Marketing category
- ANDA
- Marketing start
- 2008-03-17
- Marketing end
- 0000-00-00
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OFLOXACIN | ACTIVE INGREDIENT | A4P49JAZ9H | OFLOXACIN SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| OFLOXACIN | ACTIVE INGREDIENT | A4P49JAZ9H | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 2 | |
| OFLOXACIN | ACTIVE MOIETY | A4P49JAZ9H | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 2 | |
| OFLOXACIN | ACTIVE MOIETY | A4P49JAZ9H | OFLOXACIN SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 2 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OFLOXACIN SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OFLOXACIN SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OFLOXACIN SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OFLOXACIN SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OFLOXACIN SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 2 | |
| OFLOXACIN | ACTIVE INGREDIENT | A4P49JAZ9H | OFLOXACIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| OFLOXACIN | ACTIVE INGREDIENT | A4P49JAZ9H | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| OFLOXACIN | ACTIVE MOIETY | A4P49JAZ9H | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| OFLOXACIN | ACTIVE MOIETY | A4P49JAZ9H | OFLOXACIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OFLOXACIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OFLOXACIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OFLOXACIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OFLOXACIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OFLOXACIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-025 | OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [AKORN] | 6 | Legacy NDC | 20221018_2ec6bd57-96df-47ac-b218-1469801868b7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50383-025-05 | 50383002505 | 1 BOTTLE in 1 CARTON (50383-025-05) > 5 mL in 1 BOTTLE | 1 bottle | 2008-03-17 | 0000-00-00 | No | No | Current |
| 50383-025-10 | 50383002510 | 1 BOTTLE in 1 CARTON (50383-025-10) > 10 mL in 1 BOTTLE | 1 bottle | 2008-03-17 | 0000-00-00 | No | No | Current |