pylera

Generic: bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride

Labeler: h2-pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pylera
Generic Name bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride
Labeler h2-pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

bismuth subcitrate potassium 140 mg/1, metronidazole 125 mg/1, tetracycline hydrochloride 125 mg/1

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-380
Product ID 61269-380_07e2c55d-707f-4e3f-be0e-385da673b8ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050786
Listing Expiration 2026-12-31
Marketing Start 2023-10-01

Pharmacologic Class

Established (EPC)
nitroimidazole antimicrobial [epc]
Chemical Structure
nitroimidazoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269380
Hyphenated Format 61269-380

Supplemental Identifiers

RxCUI
1294619 1294621
UNII
R3O80H60KX 140QMO216E P6R62377KV
NUI
N0000175435 M0014907

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pylera (source: ndc)
Generic Name bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride (source: ndc)
Application Number NDA050786 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 140 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

61269-380-12 10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK

Ingredients (3)

bismuth subcitrate potassium (140 mg/1) metronidazole (125 mg/1) tetracycline hydrochloride (125 mg/1)

Linked Drug Pages (1)

PYLERA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "07e2c55d-707f-4e3f-be0e-385da673b8ee", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["R3O80H60KX", "140QMO216E", "P6R62377KV"], "rxcui": ["1294619", "1294621"], "spl_set_id": ["5cdacbf5-67be-42eb-bd54-8acc32ea1abc"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX (61269-380-12)  / 12 CAPSULE in 1 BLISTER PACK", "package_ndc": "61269-380-12", "marketing_start_date": "20231001"}], "brand_name": "PYLERA", "product_id": "61269-380_07e2c55d-707f-4e3f-be0e-385da673b8ee", "dosage_form": "CAPSULE", "pharm_class": ["Bismuth [CS]", "Bismuth [EPC]", "Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]", "Tetracycline-class Antimicrobial [EPC]", "Tetracyclines [CS]"], "product_ndc": "61269-380", "generic_name": "BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, and TETRACYCLINE HYDROCHLORIDE", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PYLERA", "active_ingredients": [{"name": "BISMUTH SUBCITRATE POTASSIUM", "strength": "140 mg/1"}, {"name": "METRONIDAZOLE", "strength": "125 mg/1"}, {"name": "TETRACYCLINE HYDROCHLORIDE", "strength": "125 mg/1"}], "application_number": "NDA050786", "marketing_category": "NDA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}