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 71335-0863
Product ID 71335-0863_caeadb30-df1d-43b3-b661-5354294102d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207372
Listing Expiration 2026-12-31
Marketing Start 2017-05-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713350863
Hyphenated Format 71335-0863

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 ANDA207372 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 6 CAPSULE in 1 BOTTLE (71335-0863-0)
  • 20 CAPSULE in 1 BOTTLE (71335-0863-1)
  • 14 CAPSULE in 1 BOTTLE (71335-0863-2)
  • 30 CAPSULE in 1 BOTTLE (71335-0863-3)
  • 28 CAPSULE in 1 BOTTLE (71335-0863-4)
  • 60 CAPSULE in 1 BOTTLE (71335-0863-5)
  • 10 CAPSULE in 1 BOTTLE (71335-0863-6)
  • 90 CAPSULE in 1 BOTTLE (71335-0863-7)
  • 21 CAPSULE in 1 BOTTLE (71335-0863-8)
  • 8 CAPSULE in 1 BOTTLE (71335-0863-9)
source: ndc

Packages (10)

71335-0863-0 6 CAPSULE in 1 BOTTLE (71335-0863-0) 71335-0863-1 20 CAPSULE in 1 BOTTLE (71335-0863-1) 71335-0863-2 14 CAPSULE in 1 BOTTLE (71335-0863-2) 71335-0863-3 30 CAPSULE in 1 BOTTLE (71335-0863-3) 71335-0863-4 28 CAPSULE in 1 BOTTLE (71335-0863-4) 71335-0863-5 60 CAPSULE in 1 BOTTLE (71335-0863-5) 71335-0863-6 10 CAPSULE in 1 BOTTLE (71335-0863-6) 71335-0863-7 90 CAPSULE in 1 BOTTLE (71335-0863-7) 71335-0863-8 21 CAPSULE in 1 BOTTLE (71335-0863-8) 71335-0863-9 8 CAPSULE in 1 BOTTLE (71335-0863-9)

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": "caeadb30-df1d-43b3-b661-5354294102d4", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["443d502c-58be-4421-8904-ffe59c4d1aba"], "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 (71335-0863-0)", "package_ndc": "71335-0863-0", "marketing_start_date": "20211227"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (71335-0863-1)", "package_ndc": "71335-0863-1", "marketing_start_date": "20180709"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (71335-0863-2)", "package_ndc": "71335-0863-2", "marketing_start_date": "20180613"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71335-0863-3)", "package_ndc": "71335-0863-3", "marketing_start_date": "20181210"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (71335-0863-4)", "package_ndc": "71335-0863-4", "marketing_start_date": "20211227"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71335-0863-5)", "package_ndc": "71335-0863-5", "marketing_start_date": "20211227"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (71335-0863-6)", "package_ndc": "71335-0863-6", "marketing_start_date": "20180830"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71335-0863-7)", "package_ndc": "71335-0863-7", "marketing_start_date": "20181207"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE (71335-0863-8)", "package_ndc": "71335-0863-8", "marketing_start_date": "20181210"}, {"sample": false, "description": "8 CAPSULE in 1 BOTTLE (71335-0863-9)", "package_ndc": "71335-0863-9", "marketing_start_date": "20211227"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "71335-0863_caeadb30-df1d-43b3-b661-5354294102d4", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "71335-0863", "generic_name": "Nitrofurantoin monohydrate/macrocrystals", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "brand_name_suffix": "(monohydrate/macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA207372", "marketing_category": "ANDA", "marketing_start_date": "20170525", "listing_expiration_date": "20261231"}