nitrofurantion

Generic: nitrofurantion

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantion
Generic Name nitrofurantion
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-233
Product ID 57664-233_163dd253-35bc-4eb8-8bfc-a3ec65c9da14
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201722
Listing Expiration 2026-12-31
Marketing Start 2016-04-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664233
Hyphenated Format 57664-233

Supplemental Identifiers

RxCUI
311994 311995 1648759
UPC
0357664231180 0357664231883 0357664233184 0357664232187
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 nitrofurantion (source: ndc)
Generic Name nitrofurantion (source: ndc)
Application Number ANDA201722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE (57664-233-18)
  • 100 CAPSULE in 1 BOTTLE (57664-233-88)
source: ndc

Packages (2)

57664-233-18 1000 CAPSULE in 1 BOTTLE (57664-233-18) 57664-233-88 100 CAPSULE in 1 BOTTLE (57664-233-88)

Ingredients (1)

nitrofurantoin (100 mg/1)

Linked Drug Pages (1)

Nitrofurantion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "163dd253-35bc-4eb8-8bfc-a3ec65c9da14", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0357664231180", "0357664231883", "0357664233184", "0357664232187"], "unii": ["927AH8112L"], "rxcui": ["311994", "311995", "1648759"], "spl_set_id": ["05f25774-f56a-48ef-bac3-8af663f8581a"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (57664-233-18)", "package_ndc": "57664-233-18", "marketing_start_date": "20160415"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (57664-233-88)", "package_ndc": "57664-233-88", "marketing_start_date": "20160415"}], "brand_name": "Nitrofurantion", "product_id": "57664-233_163dd253-35bc-4eb8-8bfc-a3ec65c9da14", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "57664-233", "generic_name": "Nitrofurantion", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantion", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA201722", "marketing_category": "ANDA", "marketing_start_date": "20160415", "listing_expiration_date": "20261231"}