nitrofurantoin

Generic: nitrofurantoin (monohydrate/macrocrystals)

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin (monohydrate/macrocrystals)
Labeler a-s medication solutions
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6769
Product ID 50090-6769_fc77d2b6-7267-4a70-a482-aabcb4673d2c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077066
Marketing Start 2014-11-01
Marketing End 2027-03-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906769
Hyphenated Format 50090-6769

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 (source: ndc)
Generic Name nitrofurantoin (monohydrate/macrocrystals) (source: ndc)
Application Number ANDA077066 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • HOW SUPPLIED Product: 50090-6769
  • NITROFURANTOIN- MONOHYDRATE/MACROCRYSTALS Label Image
source: label

Packages (0)

No package records.

Ingredients (2)

nitrofurantoin (25 mg/1) nitrofurantoin monohydrate (75 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": "fc77d2b6-7267-4a70-a482-aabcb4673d2c", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["b644426c-c8ba-4fe0-80c7-d9b2dde37395"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [], "brand_name": "Nitrofurantoin", "product_id": "50090-6769_fc77d2b6-7267-4a70-a482-aabcb4673d2c", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "50090-6769", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA077066", "marketing_category": "ANDA", "marketing_end_date": "20270318", "marketing_start_date": "20141101"}