nitrofurantoin (monohydrate/macrocrystals)

Generic: nitrofurantoin (monohydrate/macrocrystals)

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

Drug Facts

Product Profile

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

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

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2377
Product ID 71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217357
Listing Expiration 2026-12-31
Marketing Start 2023-09-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352377
Hyphenated Format 71335-2377

Supplemental Identifiers

RxCUI
1648755
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 (monohydrate/macrocrystals) (source: ndc)
Generic Name nitrofurantoin (monohydrate/macrocrystals) (source: ndc)
Application Number ANDA217357 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 6 CAPSULE in 1 BOTTLE (71335-2377-0)
  • 20 CAPSULE in 1 BOTTLE (71335-2377-1)
  • 14 CAPSULE in 1 BOTTLE (71335-2377-2)
  • 30 CAPSULE in 1 BOTTLE (71335-2377-3)
  • 28 CAPSULE in 1 BOTTLE (71335-2377-4)
  • 60 CAPSULE in 1 BOTTLE (71335-2377-5)
  • 10 CAPSULE in 1 BOTTLE (71335-2377-6)
  • 90 CAPSULE in 1 BOTTLE (71335-2377-7)
  • 21 CAPSULE in 1 BOTTLE (71335-2377-8)
  • 8 CAPSULE in 1 BOTTLE (71335-2377-9)
source: ndc

Packages (10)

71335-2377-0 6 CAPSULE in 1 BOTTLE (71335-2377-0) 71335-2377-1 20 CAPSULE in 1 BOTTLE (71335-2377-1) 71335-2377-2 14 CAPSULE in 1 BOTTLE (71335-2377-2) 71335-2377-3 30 CAPSULE in 1 BOTTLE (71335-2377-3) 71335-2377-4 28 CAPSULE in 1 BOTTLE (71335-2377-4) 71335-2377-5 60 CAPSULE in 1 BOTTLE (71335-2377-5) 71335-2377-6 10 CAPSULE in 1 BOTTLE (71335-2377-6) 71335-2377-7 90 CAPSULE in 1 BOTTLE (71335-2377-7) 71335-2377-8 21 CAPSULE in 1 BOTTLE (71335-2377-8) 71335-2377-9 8 CAPSULE in 1 BOTTLE (71335-2377-9)

Ingredients (2)

nitrofurantoin (25 mg/1) nitrofurantoin monohydrate (75 mg/1)

Linked Drug Pages (1)

Nitrofurantoin (monohydrate/macrocrystals) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "140ec378-126e-409d-8cbd-46f9e343a9ef", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["63a4b367-bf4b-4b5f-b3e9-394ba307886d"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "6 CAPSULE in 1 BOTTLE (71335-2377-0)", "package_ndc": "71335-2377-0", "marketing_start_date": "20240529"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (71335-2377-1)", "package_ndc": "71335-2377-1", "marketing_start_date": "20240529"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (71335-2377-2)", "package_ndc": "71335-2377-2", "marketing_start_date": "20240529"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71335-2377-3)", "package_ndc": "71335-2377-3", "marketing_start_date": "20240529"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (71335-2377-4)", "package_ndc": "71335-2377-4", "marketing_start_date": "20240529"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71335-2377-5)", "package_ndc": "71335-2377-5", "marketing_start_date": "20240529"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (71335-2377-6)", "package_ndc": "71335-2377-6", "marketing_start_date": "20240529"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71335-2377-7)", "package_ndc": "71335-2377-7", "marketing_start_date": "20240529"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE (71335-2377-8)", "package_ndc": "71335-2377-8", "marketing_start_date": "20240529"}, {"sample": false, "description": "8 CAPSULE in 1 BOTTLE (71335-2377-9)", "package_ndc": "71335-2377-9", "marketing_start_date": "20240529"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "71335-2377", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin (monohydrate/macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA217357", "marketing_category": "ANDA", "marketing_start_date": "20230914", "listing_expiration_date": "20261231"}