metronidazole

Generic: metronidazole

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

metronidazole 500 mg/100mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-993
Product ID 47335-993_9549fa19-5d89-4ad8-82ac-5d023072b126
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212435
Listing Expiration 2026-12-31
Marketing Start 2021-08-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335993
Hyphenated Format 47335-993

Supplemental Identifiers

RxCUI
311683
UPC
0347335993011
UNII
140QMO216E
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 metronidazole (source: ndc)
Generic Name metronidazole (source: ndc)
Application Number ANDA212435 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 1 BAG in 1 POUCH (47335-993-01) / 100 mL in 1 BAG
source: ndc

Packages (1)

47335-993-01 1 BAG in 1 POUCH (47335-993-01) / 100 mL in 1 BAG

Ingredients (1)

metronidazole (500 mg/100mL)

Linked Drug Pages (1)

METRONIDAZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9549fa19-5d89-4ad8-82ac-5d023072b126", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0347335993011"], "unii": ["140QMO216E"], "rxcui": ["311683"], "spl_set_id": ["7187779a-1f4c-4607-af53-4119e324aad5"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 POUCH (47335-993-01)  / 100 mL in 1 BAG", "package_ndc": "47335-993-01", "marketing_start_date": "20210810"}], "brand_name": "METRONIDAZOLE", "product_id": "47335-993_9549fa19-5d89-4ad8-82ac-5d023072b126", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "47335-993", "generic_name": "metronidazole", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METRONIDAZOLE", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/100mL"}], "application_number": "ANDA212435", "marketing_category": "ANDA", "marketing_start_date": "20210810", "listing_expiration_date": "20261231"}