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NDC 61269-0380-12 PYLERA 140; 125; 125 mg/1; mg/1; mg/1 Details
PYLERA 140; 125; 125 mg/1; mg/1; mg/1
PYLERA is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by H2-Pharma, LLC. The primary component is BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Bismuth, metronidazole, and tetracycline is used along with other ulcer medications to treat duodenal ulcers. It is in a class of medications called antibacterial agents. It works by preventing the growth and spread of Helicobacter pylori bacteria, which often occurs with ulcers. Treating this infection keeps ulcers from coming back.
Related Packages: 61269-0380-12Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Bismuth, Metronidazole, and Tetracycline
Product Information
| NDC | 61269-0380 |
|---|---|
| Product ID | 61269-380_e0ed7e4a-7b77-488c-9864-e09e4dad8289 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | PYLERA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, and TETRACYCLINE HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 140; 125; 125 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
| Labeler Name | H2-Pharma, LLC |
| Pharmaceutical Class | Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050786 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 61269-0380-12 (61269038012)
| NDC Package Code | 61269-380-12 |
|---|---|
| Billing NDC | 61269038012 |
| Package | 10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2023-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |