nitrofurantoin monohydrate/ macrocrystalline

Generic: nitrofurantoin monohydrate/macrocrystalline

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin monohydrate/ macrocrystalline
Generic Name nitrofurantoin monohydrate/macrocrystalline
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7137
Product ID 0904-7137_06bb1817-bab0-4230-971e-06feab3d3dcd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020064
Marketing Start 2011-05-25
Marketing End 2026-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047137
Hyphenated Format 0904-7137

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/ 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
  • 100 BLISTER PACK in 1 CARTON (0904-7137-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7137-61 100 BLISTER PACK in 1 CARTON (0904-7137-61) / 1 CAPSULE in 1 BLISTER PACK

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": "06bb1817-bab0-4230-971e-06feab3d3dcd", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["b2c95493-7bd7-414c-8ea8-61d55c5cedca"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7137-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7137-61", "marketing_end_date": "20260531", "marketing_start_date": "20230605"}], "brand_name": "Nitrofurantoin Monohydrate/ Macrocrystalline", "product_id": "0904-7137_06bb1817-bab0-4230-971e-06feab3d3dcd", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "0904-7137", "generic_name": "Nitrofurantoin Monohydrate/Macrocrystalline", "labeler_name": "Major Pharmaceuticals", "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_end_date": "20260531", "marketing_start_date": "20110525"}