| NDC Code | 61269-380-12 |
|---|
| Package Description | 10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK |
|---|
| Product NDC | 61269-380 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Pylera |
|---|
| Non-Proprietary Name | Bismuth Subcitrate Potassium, Metronidazole, And Tetracycline Hydrochloride |
|---|
| Dosage Form | CAPSULE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20231001 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA050786 |
|---|
| Manufacturer | H2-Pharma, LLC |
|---|
| Substance Name | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
|---|
| Strength | 140; 125; 125 |
|---|
| Strength Unit | mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS] |
|---|