nitrofurantoin

Generic: nitrofurantoin

Labeler: novel laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler novel laboratories, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nitrofurantoin 25 mg/5mL

Manufacturer
Novel Laboratories, Inc.

Identifiers & Regulatory

Product NDC 40032-450
Product ID 40032-450_f62f5875-c0f1-4892-95c4-a811d8b6f1de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201693
Listing Expiration 2026-12-31
Marketing Start 2014-09-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 40032450
Hyphenated Format 40032-450

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 ANDA201693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (40032-450-11) / 230 mL in 1 BOTTLE
source: ndc

Packages (1)

40032-450-11 1 BOTTLE in 1 CARTON (40032-450-11) / 230 mL in 1 BOTTLE

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": "f62f5875-c0f1-4892-95c4-a811d8b6f1de", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311989"], "spl_set_id": ["499f9dfd-b533-4021-a3ed-308f0f956c79"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Novel Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (40032-450-11)  / 230 mL in 1 BOTTLE", "package_ndc": "40032-450-11", "marketing_start_date": "20140908"}], "brand_name": "Nitrofurantoin", "product_id": "40032-450_f62f5875-c0f1-4892-95c4-a811d8b6f1de", "dosage_form": "SUSPENSION", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "40032-450", "generic_name": "Nitrofurantoin", "labeler_name": "Novel Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/5mL"}], "application_number": "ANDA201693", "marketing_category": "ANDA", "marketing_start_date": "20140908", "listing_expiration_date": "20261231"}