NDC 71384-502
Pred-Gati
Prednisolone Acetate-gatifloxacin
Pred-Gati is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Imprimis Njof, Llc. The primary component is Gatifloxacin; Prednisolone Acetate.
| Product ID | 71384-502_6389e970-c7dd-958e-e053-2a91aa0acb11 |
| NDC | 71384-502 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Pred-Gati |
| Generic Name | Prednisolone Acetate-gatifloxacin |
| Dosage Form | Suspension/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2018-01-05 |
| Marketing Category | UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER |
| Labeler Name | Imprimis NJOF, LLC |
| Substance Name | GATIFLOXACIN; PREDNISOLONE ACETATE |
| Active Ingredient Strength | 5 mg/mL; mg/mL |
| Pharm Classes | Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 71384-502-03
20 BOTTLE, DROPPER in 1 BOX (71384-502-03) > 3.5 mL in 1 BOTTLE, DROPPER
| Marketing Start Date | 2018-01-05 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 71384-502-03 [71384050203]
Pred-Gati SUSPENSION/ DROPS
| Marketing Category | unapproved drug other |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-01-05 |
| Marketing End Date | 2019-07-01 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-12 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GATIFLOXACIN | 5 mg/mL |
OpenFDA Data
| SPL SET ID: | 6326b43a-bbac-4696-e053-2a91aa0a73fb |
| Manufacturer | |
| UNII |
Pharmacological Class
- Quinolone Antimicrobial [EPC]
- Quinolones [CS]
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
NDC Crossover Matching brand name "Pred-Gati" or generic name "Prednisolone Acetate-gatifloxacin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70261-502 | Pred-Gati | Prednisolone-Gatifloxacin |
| 71384-502 | Pred-Gati | Prednisolone Acetate-Gatifloxacin |
Trademark Results [Pred-Gati]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRED-GATI 87180492 5342159 Live/Registered |
HARROW IP, LLC 2016-09-22 |
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