nitrofurantoin monohydrate macrocrystalline

Generic: nitrofurantoin monohydrate

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin monohydrate macrocrystalline
Generic Name nitrofurantoin monohydrate
Labeler direct_rx
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-021
Product ID 61919-021_397f7645-278c-731e-e063-6294a90a2d3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020064
Listing Expiration 2026-12-31
Marketing Start 2019-07-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919021
Hyphenated Format 61919-021

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 (source: ndc)
Application Number NDA020064 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 2 CAPSULE in 1 BOTTLE (61919-021-02)
  • 10 CAPSULE in 1 BOTTLE (61919-021-10)
  • 14 CAPSULE in 1 BOTTLE (61919-021-14)
source: ndc

Packages (3)

61919-021-02 2 CAPSULE in 1 BOTTLE (61919-021-02) 61919-021-10 10 CAPSULE in 1 BOTTLE (61919-021-10) 61919-021-14 14 CAPSULE in 1 BOTTLE (61919-021-14)

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": "397f7645-278c-731e-e063-6294a90a2d3f", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["8d2e456a-ffb2-3f1e-e053-2995a90a22df"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "2 CAPSULE in 1 BOTTLE (61919-021-02)", "package_ndc": "61919-021-02", "marketing_start_date": "20190708"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (61919-021-10)", "package_ndc": "61919-021-10", "marketing_start_date": "20190708"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (61919-021-14)", "package_ndc": "61919-021-14", "marketing_start_date": "20190708"}], "brand_name": "NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE", "product_id": "61919-021_397f7645-278c-731e-e063-6294a90a2d3f", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "61919-021", "generic_name": "NITROFURANTOIN MONOHYDRATE", "labeler_name": "Direct_Rx", "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": "20190708", "listing_expiration_date": "20261231"}