nitrofurantoin

Generic: nitrofurantoin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 25 mg/1, nitrofurantoin monohydrate 75 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-852
Product ID 71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208516
Listing Expiration 2026-12-31
Marketing Start 2018-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205852
Hyphenated Format 71205-852

Supplemental Identifiers

RxCUI
1648755
UPC
0371205852108
UNII
927AH8112L E1QI2CQQ1I
NUI
N0000175494 M0014892

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 ANDA208516 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (71205-852-00)
  • 10 CAPSULE in 1 BOTTLE (71205-852-10)
  • 14 CAPSULE in 1 BOTTLE (71205-852-14)
  • 20 CAPSULE in 1 BOTTLE (71205-852-20)
  • 30 CAPSULE in 1 BOTTLE (71205-852-30)
  • 500 CAPSULE in 1 BOTTLE (71205-852-55)
source: ndc

Packages (6)

71205-852-00 100 CAPSULE in 1 BOTTLE (71205-852-00) 71205-852-10 10 CAPSULE in 1 BOTTLE (71205-852-10) 71205-852-14 14 CAPSULE in 1 BOTTLE (71205-852-14) 71205-852-20 20 CAPSULE in 1 BOTTLE (71205-852-20) 71205-852-30 30 CAPSULE in 1 BOTTLE (71205-852-30) 71205-852-55 500 CAPSULE in 1 BOTTLE (71205-852-55)

Ingredients (2)

nitrofurantoin (25 mg/1) nitrofurantoin monohydrate (75 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": "34d3c103-27b8-454b-9f38-c33157c3b6fc", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0371205852108"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["34d3c103-27b8-454b-9f38-c33157c3b6fc"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (71205-852-00)", "package_ndc": "71205-852-00", "marketing_start_date": "20221123"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (71205-852-10)", "package_ndc": "71205-852-10", "marketing_start_date": "20221123"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (71205-852-14)", "package_ndc": "71205-852-14", "marketing_start_date": "20221123"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (71205-852-20)", "package_ndc": "71205-852-20", "marketing_start_date": "20221123"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71205-852-30)", "package_ndc": "71205-852-30", "marketing_start_date": "20221123"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (71205-852-55)", "package_ndc": "71205-852-55", "marketing_start_date": "20221123"}], "brand_name": "Nitrofurantoin", "product_id": "71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "71205-852", "generic_name": "Nitrofurantoin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA208516", "marketing_category": "ANDA", "marketing_start_date": "20180101", "listing_expiration_date": "20261231"}