nitrofurantoin

Generic: nitrofurantoin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler rising pharma holdings, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nitrofurantoin monohydrate 25 mg/5mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-593
Product ID 64980-593_dfecf83b-2b30-4505-9044-bec3dce43a39
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 64980593
Hyphenated Format 64980-593

Supplemental Identifiers

RxCUI
311989
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 (64980-593-24) / 230 mL in 1 BOTTLE
source: ndc

Packages (1)

64980-593-24 1 BOTTLE in 1 CARTON (64980-593-24) / 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": "dfecf83b-2b30-4505-9044-bec3dce43a39", "openfda": {"unii": ["E1QI2CQQ1I"], "rxcui": ["311989"], "spl_set_id": ["11e700aa-66f9-4939-8a6b-a23240ae1a0b"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (64980-593-24)  / 230 mL in 1 BOTTLE", "package_ndc": "64980-593-24", "marketing_start_date": "20230511"}], "brand_name": "Nitrofurantoin", "product_id": "64980-593_dfecf83b-2b30-4505-9044-bec3dce43a39", "dosage_form": "SUSPENSION", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "64980-593", "generic_name": "Nitrofurantoin", "labeler_name": "Rising Pharma Holdings, Inc.", "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"}