Ofloxacin
- Product NDC
- 50436-6112
- 11-digit product format
- 504366112
- Labeler code
- 50436
- Product ID
- 50436-6112_701c61c5-5588-410d-a69e-c492e35321dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Unit Dose Services
- Application
- ANDA076622
- Marketing category
- ANDA
- Marketing start
- 2004-05-14
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-6112-0 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2264-a910-e053-dadaa90a0b85 | Ofloxacin Ophthalmic Solution 0.3% (Sterile) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-6112-0 | Ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-6112-0 | ML - Milliliter | 50436-6112 | 45e3c47d-c796-4d18-9c0a-6a866659d574 | 1 | 2014-12-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OFLOXACIN | ACTIVE INGREDIENT | A4P49JAZ9H | OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES] | 2 | |
| OFLOXACIN | ACTIVE MOIETY | A4P49JAZ9H | OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES] | 2 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-6112 | OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES] | 4 | Legacy NDC, 1 package rows | 20170311_1f42711d-f960-4832-acf5-97096aa6ad77.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | 1f42711d-f960-4832-acf5-97096aa6ad77 | 4 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | 1f42711d-f960-4832-acf5-97096aa6ad77 | 4 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | 1f42711d-f960-4832-acf5-97096aa6ad77 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 50436-6112-0 | 50436611200 | 5 mL in 1 BOTTLE, DROPPER | 5 ml | Historical |