metronidazole

Generic: metronidazole

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3265
Product ID 70518-3265_468a45b2-b376-08c9-e063-6294a90a98f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205245
Listing Expiration 2026-12-31
Marketing Start 2021-11-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183265
Hyphenated Format 70518-3265

Supplemental Identifiers

RxCUI
311681
UNII
140QMO216E
NUI
N0000175435 M0014907

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 metronidazole (source: ndc)
Generic Name metronidazole (source: ndc)
Application Number ANDA205245 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE, PLASTIC (70518-3265-1)
  • 14 TABLET in 1 BOTTLE, PLASTIC (70518-3265-2)
  • 20 TABLET in 1 BOTTLE, PLASTIC (70518-3265-4)
  • 30 TABLET in 1 BLISTER PACK (70518-3265-5)
source: ndc

Packages (4)

70518-3265-1 4 TABLET in 1 BOTTLE, PLASTIC (70518-3265-1) 70518-3265-2 14 TABLET in 1 BOTTLE, PLASTIC (70518-3265-2) 70518-3265-4 20 TABLET in 1 BOTTLE, PLASTIC (70518-3265-4) 70518-3265-5 30 TABLET in 1 BLISTER PACK (70518-3265-5)

Ingredients (1)

metronidazole (500 mg/1)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "468a45b2-b376-08c9-e063-6294a90a98f0", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681"], "spl_set_id": ["5cc3fd98-d579-432e-a4b5-b6d5586991a6"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (70518-3265-1)", "package_ndc": "70518-3265-1", "marketing_start_date": "20220210"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (70518-3265-2)", "package_ndc": "70518-3265-2", "marketing_start_date": "20220417"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (70518-3265-4)", "package_ndc": "70518-3265-4", "marketing_start_date": "20251003"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3265-5)", "package_ndc": "70518-3265-5", "marketing_start_date": "20251220"}], "brand_name": "Metronidazole", "product_id": "70518-3265_468a45b2-b376-08c9-e063-6294a90a98f0", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "70518-3265", "generic_name": "METRONIDAZOLE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA205245", "marketing_category": "ANDA", "marketing_start_date": "20211108", "listing_expiration_date": "20261231"}