nitrofurantoin

Generic: nitrofurantoin macrocrystals

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin macrocrystals
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1069
Product ID 71335-1069_05e89273-b886-40bb-be42-7807d29f5dee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205005
Listing Expiration 2026-12-31
Marketing Start 2018-02-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713351069
Hyphenated Format 71335-1069

Supplemental Identifiers

RxCUI
1648759
UNII
927AH8112L
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 macrocrystals (source: ndc)
Application Number ANDA205005 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 40 CAPSULE in 1 BOTTLE (71335-1069-1)
  • 28 CAPSULE in 1 BOTTLE (71335-1069-2)
  • 30 CAPSULE in 1 BOTTLE (71335-1069-3)
  • 20 CAPSULE in 1 BOTTLE (71335-1069-4)
  • 14 CAPSULE in 1 BOTTLE (71335-1069-5)
  • 10 CAPSULE in 1 BOTTLE (71335-1069-6)
  • 12 CAPSULE in 1 BOTTLE (71335-1069-7)
  • 90 CAPSULE in 1 BOTTLE (71335-1069-8)
  • 6 CAPSULE in 1 BOTTLE (71335-1069-9)
source: ndc

Packages (9)

71335-1069-1 40 CAPSULE in 1 BOTTLE (71335-1069-1) 71335-1069-2 28 CAPSULE in 1 BOTTLE (71335-1069-2) 71335-1069-3 30 CAPSULE in 1 BOTTLE (71335-1069-3) 71335-1069-4 20 CAPSULE in 1 BOTTLE (71335-1069-4) 71335-1069-5 14 CAPSULE in 1 BOTTLE (71335-1069-5) 71335-1069-6 10 CAPSULE in 1 BOTTLE (71335-1069-6) 71335-1069-7 12 CAPSULE in 1 BOTTLE (71335-1069-7) 71335-1069-8 90 CAPSULE in 1 BOTTLE (71335-1069-8) 71335-1069-9 6 CAPSULE in 1 BOTTLE (71335-1069-9)

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": "05e89273-b886-40bb-be42-7807d29f5dee", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["aca04d52-8a64-4fca-94b2-64b46f5a3218"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "40 CAPSULE in 1 BOTTLE (71335-1069-1)", "package_ndc": "71335-1069-1", "marketing_start_date": "20240517"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (71335-1069-2)", "package_ndc": "71335-1069-2", "marketing_start_date": "20240517"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71335-1069-3)", "package_ndc": "71335-1069-3", "marketing_start_date": "20240517"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (71335-1069-4)", "package_ndc": "71335-1069-4", "marketing_start_date": "20240517"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (71335-1069-5)", "package_ndc": "71335-1069-5", "marketing_start_date": "20190121"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (71335-1069-6)", "package_ndc": "71335-1069-6", "marketing_start_date": "20190225"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE (71335-1069-7)", "package_ndc": "71335-1069-7", "marketing_start_date": "20240517"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71335-1069-8)", "package_ndc": "71335-1069-8", "marketing_start_date": "20240517"}, {"sample": false, "description": "6 CAPSULE in 1 BOTTLE (71335-1069-9)", "package_ndc": "71335-1069-9", "marketing_start_date": "20240517"}], "brand_name": "nitrofurantoin", "product_id": "71335-1069_05e89273-b886-40bb-be42-7807d29f5dee", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "71335-1069", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA205005", "marketing_category": "ANDA", "marketing_start_date": "20180215", "listing_expiration_date": "20261231"}