bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride

Generic: bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride
Generic Name bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride
Labeler ingenus pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-283
Product ID 50742-283_6842c7a1-52e9-4047-81e1-22da3ec35505
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217511
Listing Expiration 2026-12-31
Marketing Start 2023-07-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742283
Hyphenated Format 50742-283

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, tetracycline hydrochloride (source: ndc)
Generic Name bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride (source: ndc)
Application Number ANDA217511 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 140 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 120 CAPSULE in 1 CARTON (50742-283-13)
source: ndc

Packages (1)

50742-283-13 120 CAPSULE in 1 CARTON (50742-283-13)

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, Tetracycline hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6842c7a1-52e9-4047-81e1-22da3ec35505", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["R3O80H60KX", "140QMO216E", "P6R62377KV"], "rxcui": ["1294619"], "spl_set_id": ["4c7f024d-ba26-43cf-a36f-597e2168cd9f"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 CARTON (50742-283-13)", "package_ndc": "50742-283-13", "marketing_start_date": "20230704"}], "brand_name": "Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride", "product_id": "50742-283_6842c7a1-52e9-4047-81e1-22da3ec35505", "dosage_form": "CAPSULE", "pharm_class": ["Bismuth [CS]", "Bismuth [EPC]", "Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]", "Tetracycline-class Antimicrobial [EPC]", "Tetracyclines [CS]"], "product_ndc": "50742-283", "generic_name": "Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bismuth subcitrate potassium, Metronidazole, 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": "ANDA217511", "marketing_category": "ANDA", "marketing_start_date": "20230704", "listing_expiration_date": "20261231"}