nitrofurantoin

Generic: nitrofurantoin

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler lupin pharmaceuticals,inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nitrofurantoin 25 mg/5mL

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-450
Product ID 43386-450_361dd255-19ba-453f-9b68-ade3185ff390
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201693
Listing Expiration 2026-12-31
Marketing Start 2015-05-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386450
Hyphenated Format 43386-450

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 (43386-450-11) / 230 mL in 1 BOTTLE
source: ndc

Packages (1)

43386-450-11 1 BOTTLE in 1 CARTON (43386-450-11) / 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": "361dd255-19ba-453f-9b68-ade3185ff390", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311989"], "spl_set_id": ["93c37857-38f1-4e2e-acb8-4846840e3e85"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43386-450-11)  / 230 mL in 1 BOTTLE", "package_ndc": "43386-450-11", "marketing_start_date": "20150521"}], "brand_name": "Nitrofurantoin", "product_id": "43386-450_361dd255-19ba-453f-9b68-ade3185ff390", "dosage_form": "SUSPENSION", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "43386-450", "generic_name": "Nitrofurantoin", "labeler_name": "Lupin Pharmaceuticals,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": "20150521", "listing_expiration_date": "20261231"}