Gatifloxacin
- Product NDC
- 50383-189
- 11-digit product format
- 503830189
- Labeler code
- 50383
- Product ID
- 50383-189_2145dbd3-6bcf-4473-b30b-7ad660f83cad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gatifloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA203189
- Marketing category
- ANDA
- Marketing start
- 2014-10-06
- Marketing end
- 0000-00-00
- Substance
- GATIFLOXACIN ANHYDROUS
- Active strength
- 5 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50383-189-02 | Gatifloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
| 50383-189-02 | Gatifloxacin | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GATIFLOXACIN ANHYDROUS | ACTIVE INGREDIENT | 81485Y3A9A | GATIFLOXACIN SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 3 | |
| GATIFLOXACIN ANHYDROUS | ACTIVE MOIETY | 81485Y3A9A | GATIFLOXACIN SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 3 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | GATIFLOXACIN SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | GATIFLOXACIN SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 3 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | GATIFLOXACIN SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | GATIFLOXACIN SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | GATIFLOXACIN SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GATIFLOXACIN SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-189 | GATIFLOXACIN SOLUTION/ DROPS [AKORN] | 7 | Legacy NDC, 2 package rows | 20220312_14312de6-67d4-4de2-854c-ef764090dd83.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50383-189-02 | 50383018902 | 1 BOTTLE, DROPPER in 1 CARTON (50383-189-02) > 2.5 mL in 1 BOTTLE, DROPPER | 2014-10-06 | 0000-00-00 | No | No | Current |