bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride

Generic: bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA 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 endo usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-151
Product ID 49884-151_11504f8f-0a04-45bc-bcd3-711dbee7f56a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205770
Listing Expiration 2026-12-31
Marketing Start 2023-03-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884151
Hyphenated Format 49884-151

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 ANDA205770 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 140 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 120 CAPSULE in 1 CARTON (49884-151-54)
source: ndc

Packages (1)

49884-151-54 120 CAPSULE in 1 CARTON (49884-151-54)

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": "11504f8f-0a04-45bc-bcd3-711dbee7f56a", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["R3O80H60KX", "140QMO216E", "P6R62377KV"], "rxcui": ["1294619"], "spl_set_id": ["c4d66e80-f0bc-4e64-a0f0-630ef673da1b"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 CARTON (49884-151-54)", "package_ndc": "49884-151-54", "marketing_start_date": "20230307"}], "brand_name": "Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride", "product_id": "49884-151_11504f8f-0a04-45bc-bcd3-711dbee7f56a", "dosage_form": "CAPSULE", "pharm_class": ["Bismuth [CS]", "Bismuth [EPC]", "Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]", "Tetracycline-class Antimicrobial [EPC]", "Tetracyclines [CS]"], "product_ndc": "49884-151", "generic_name": "Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride", "labeler_name": "Endo USA, Inc.", "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": "ANDA205770", "marketing_category": "ANDA", "marketing_start_date": "20230307", "listing_expiration_date": "20261231"}