metronidazole

Generic: metronidazole

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

metronidazole 375 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-435
Product ID 46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079065
Listing Expiration 2026-12-31
Marketing Start 2016-12-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708435
Hyphenated Format 46708-435

Supplemental Identifiers

RxCUI
199055
UPC
0346708435301
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 ANDA079065 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (46708-435-30)
  • 100 CAPSULE in 1 BOTTLE (46708-435-31)
  • 50 CAPSULE in 1 BOTTLE (46708-435-50)
  • 500 CAPSULE in 1 BOTTLE (46708-435-71)
  • 1000 CAPSULE in 1 BOTTLE (46708-435-91)
source: ndc

Packages (5)

46708-435-30 30 CAPSULE in 1 BOTTLE (46708-435-30) 46708-435-31 100 CAPSULE in 1 BOTTLE (46708-435-31) 46708-435-50 50 CAPSULE in 1 BOTTLE (46708-435-50) 46708-435-71 500 CAPSULE in 1 BOTTLE (46708-435-71) 46708-435-91 1000 CAPSULE in 1 BOTTLE (46708-435-91)

Ingredients (1)

metronidazole (375 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": "73035cba-781b-4d60-80bb-8f8ff273a0a1", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0346708435301"], "unii": ["140QMO216E"], "rxcui": ["199055"], "spl_set_id": ["387053e5-7eda-4282-b58a-5789430a2e99"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (46708-435-30)", "package_ndc": "46708-435-30", "marketing_start_date": "20161209"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (46708-435-31)", "package_ndc": "46708-435-31", "marketing_start_date": "20161209"}, {"sample": false, "description": "50 CAPSULE in 1 BOTTLE (46708-435-50)", "package_ndc": "46708-435-50", "marketing_start_date": "20161209"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (46708-435-71)", "package_ndc": "46708-435-71", "marketing_start_date": "20161209"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (46708-435-91)", "package_ndc": "46708-435-91", "marketing_start_date": "20161209"}], "brand_name": "Metronidazole", "product_id": "46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1", "dosage_form": "CAPSULE", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "46708-435", "generic_name": "metronidazole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "375 mg/1"}], "application_number": "ANDA079065", "marketing_category": "ANDA", "marketing_start_date": "20161209", "listing_expiration_date": "20261231"}