nitrofurantoin

Generic: nitrofurantoin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler aurobindo pharma limited
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nitrofurantoin monohydrate 25 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-206
Product ID 59651-206_30c5502b-09bd-4fd7-bec8-aba74d302e09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212607
Listing Expiration 2026-12-31
Marketing Start 2023-05-11

Pharmacologic Class

Classes
nitrofuran antibacterial [epc] nitrofurans [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651206
Hyphenated Format 59651-206

Supplemental Identifiers

UPC
0359651206232
UNII
E1QI2CQQ1I

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 ANDA212607 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-206-23) / 230 mL in 1 BOTTLE
source: ndc

Packages (1)

59651-206-23 1 BOTTLE in 1 CARTON (59651-206-23) / 230 mL in 1 BOTTLE

Ingredients (1)

nitrofurantoin monohydrate (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": "30c5502b-09bd-4fd7-bec8-aba74d302e09", "openfda": {"upc": ["0359651206232"], "unii": ["E1QI2CQQ1I"], "spl_set_id": ["e9d10eaa-cf9c-469e-82ef-5af7285f2c86"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-206-23)  / 230 mL in 1 BOTTLE", "package_ndc": "59651-206-23", "marketing_start_date": "20230511"}], "brand_name": "Nitrofurantoin", "product_id": "59651-206_30c5502b-09bd-4fd7-bec8-aba74d302e09", "dosage_form": "SUSPENSION", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "59651-206", "generic_name": "Nitrofurantoin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN MONOHYDRATE", "strength": "25 mg/5mL"}], "application_number": "ANDA212607", "marketing_category": "ANDA", "marketing_start_date": "20230511", "listing_expiration_date": "20261231"}