bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride

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 bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride
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 61269-385
Product ID 61269-385_b65c614b-ec8f-43cb-8d93-d948a269483a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050786
Marketing Start 2023-07-31
Marketing End 2026-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269385
Hyphenated Format 61269-385

Supplemental Identifiers

RxCUI
1294619
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 bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride (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
  • 1 BLISTER PACK in 1 BOX (61269-385-12) / 120 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

61269-385-12 1 BLISTER PACK in 1 BOX (61269-385-12) / 120 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)

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b65c614b-ec8f-43cb-8d93-d948a269483a", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["R3O80H60KX", "140QMO216E", "P6R62377KV"], "rxcui": ["1294619"], "spl_set_id": ["c07e32ee-cd99-405d-b5e2-927d9cb204ee"], "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": "1 BLISTER PACK in 1 BOX (61269-385-12)  / 120 CAPSULE in 1 BLISTER PACK", "package_ndc": "61269-385-12", "marketing_end_date": "20260430", "marketing_start_date": "20230731"}], "brand_name": "BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE", "product_id": "61269-385_b65c614b-ec8f-43cb-8d93-d948a269483a", "dosage_form": "CAPSULE", "pharm_class": ["Bismuth [CS]", "Bismuth [EPC]", "Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]", "Tetracycline-class Antimicrobial [EPC]", "Tetracyclines [CS]"], "product_ndc": "61269-385", "generic_name": "BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE", "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_end_date": "20260430", "marketing_start_date": "20230731"}