nitrofurantoin

Generic: nitrofurantoin

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler micro labs limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-393
Product ID 42571-393_35155f61-5d28-d364-e063-6294a90aa4c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217073
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571393
Hyphenated Format 42571-393

Supplemental Identifiers

RxCUI
1648755
UPC
0342571393908
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 ANDA217073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42571-393-01)
  • 500 CAPSULE in 1 BOTTLE (42571-393-05)
  • 90 CAPSULE in 1 BOTTLE (42571-393-90)
source: ndc

Packages (3)

42571-393-01 100 CAPSULE in 1 BOTTLE (42571-393-01) 42571-393-05 500 CAPSULE in 1 BOTTLE (42571-393-05) 42571-393-90 90 CAPSULE in 1 BOTTLE (42571-393-90)

Ingredients (1)

nitrofurantoin (100 mg/1)

Linked Drug Pages (1)

Nitrofurantoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35155f61-5d28-d364-e063-6294a90aa4c6", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0342571393908"], "unii": ["927AH8112L"], "rxcui": ["1648755"], "spl_set_id": ["d96098d0-3c2b-4e53-a3f0-3ebba81c4133"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42571-393-01)", "package_ndc": "42571-393-01", "marketing_start_date": "20240401"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (42571-393-05)", "package_ndc": "42571-393-05", "marketing_start_date": "20240401"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (42571-393-90)", "package_ndc": "42571-393-90", "marketing_start_date": "20240401"}], "brand_name": "Nitrofurantoin", "product_id": "42571-393_35155f61-5d28-d364-e063-6294a90aa4c6", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "42571-393", "generic_name": "Nitrofurantoin", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA217073", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}