nitrofurantoin monohydrate/ macrocrystalline

Generic: nitrofurantoin monohydrate/macrocrystalline

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

Drug Facts

Product Profile

Brand Name nitrofurantoin monohydrate/ macrocrystalline
Generic Name nitrofurantoin monohydrate/macrocrystalline
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 63187-263
Product ID 63187-263_46ff38b8-3cbb-4e18-b66f-703b572a37f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020064
Listing Expiration 2026-12-31
Marketing Start 2011-05-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187263
Hyphenated Format 63187-263

Supplemental Identifiers

RxCUI
1648755
UPC
0363187263102
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/ macrocrystalline (source: ndc)
Generic Name nitrofurantoin monohydrate/macrocrystalline (source: ndc)
Application Number NDA020064 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (63187-263-10)
  • 14 CAPSULE in 1 BOTTLE (63187-263-14)
  • 28 CAPSULE in 1 BOTTLE (63187-263-28)
  • 30 CAPSULE in 1 BOTTLE (63187-263-30)
  • 60 CAPSULE in 1 BOTTLE (63187-263-60)
source: ndc

Packages (5)

63187-263-10 10 CAPSULE in 1 BOTTLE (63187-263-10) 63187-263-14 14 CAPSULE in 1 BOTTLE (63187-263-14) 63187-263-28 28 CAPSULE in 1 BOTTLE (63187-263-28) 63187-263-30 30 CAPSULE in 1 BOTTLE (63187-263-30) 63187-263-60 60 CAPSULE in 1 BOTTLE (63187-263-60)

Ingredients (2)

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

Linked Drug Pages (1)

Nitrofurantoin Monohydrate/ Macrocrystalline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46ff38b8-3cbb-4e18-b66f-703b572a37f6", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0363187263102"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["22061f76-2c05-4501-b8dd-a5c372abe7c2"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (63187-263-10)", "package_ndc": "63187-263-10", "marketing_start_date": "20181101"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (63187-263-14)", "package_ndc": "63187-263-14", "marketing_start_date": "20181101"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (63187-263-28)", "package_ndc": "63187-263-28", "marketing_start_date": "20181101"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63187-263-30)", "package_ndc": "63187-263-30", "marketing_start_date": "20181101"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (63187-263-60)", "package_ndc": "63187-263-60", "marketing_start_date": "20181101"}], "brand_name": "Nitrofurantoin Monohydrate/ Macrocrystalline", "product_id": "63187-263_46ff38b8-3cbb-4e18-b66f-703b572a37f6", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "63187-263", "generic_name": "Nitrofurantoin Monohydrate/Macrocrystalline", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin Monohydrate/ Macrocrystalline", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "NDA020064", "marketing_category": "NDA", "marketing_start_date": "20110525", "listing_expiration_date": "20261231"}