nitrofurantoin

Generic: nitrofurantoin

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

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler amneal pharmaceuticals llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nitrofurantoin 25 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-689
Product ID 65162-689_96cbbaac-bd28-443c-bc4c-967fa09a2f99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201679
Listing Expiration 2026-12-31
Marketing Start 2011-03-24

Pharmacologic Class

Established (EPC)
nitrofuran antibacterial [epc]
Chemical Structure
nitrofurans [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162689
Hyphenated Format 65162-689

Supplemental Identifiers

RxCUI
311989
UNII
927AH8112L
NUI
N0000175494 M0014892

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 nitrofurantoin (source: ndc)
Generic Name nitrofurantoin (source: ndc)
Application Number ANDA201679 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 230 mL in 1 BOTTLE, GLASS (65162-689-88)
source: ndc

Packages (1)

65162-689-88 230 mL in 1 BOTTLE, GLASS (65162-689-88)

Ingredients (1)

nitrofurantoin (25 mg/5mL)

Linked Drug Pages (1)

Nitrofurantoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "96cbbaac-bd28-443c-bc4c-967fa09a2f99", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311989"], "spl_set_id": ["11dcea9c-0c62-4153-976b-bd1f8ef1f6d9"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "230 mL in 1 BOTTLE, GLASS (65162-689-88)", "package_ndc": "65162-689-88", "marketing_start_date": "20110324"}], "brand_name": "Nitrofurantoin", "product_id": "65162-689_96cbbaac-bd28-443c-bc4c-967fa09a2f99", "dosage_form": "SUSPENSION", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "65162-689", "generic_name": "Nitrofurantoin", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/5mL"}], "application_number": "ANDA201679", "marketing_category": "ANDA", "marketing_start_date": "20110324", "listing_expiration_date": "20261231"}