nitrofurantoin monohydrate/macrocrystal

Generic: nitrofurantoin monohydrate/macrocrystal

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin monohydrate/macrocrystal
Generic Name nitrofurantoin monohydrate/macrocrystal
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 72189-395
Product ID 72189-395_1e79886c-8ce2-c6ef-e063-6394a90a7a83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208516
Listing Expiration 2026-12-31
Marketing Start 2022-11-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189395
Hyphenated Format 72189-395

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/macrocrystal (source: ndc)
Generic Name nitrofurantoin monohydrate/macrocrystal (source: ndc)
Application Number ANDA208516 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (72189-395-10)
  • 14 CAPSULE in 1 BOTTLE (72189-395-14)
  • 20 CAPSULE in 1 BOTTLE (72189-395-20)
source: ndc

Packages (3)

72189-395-10 10 CAPSULE in 1 BOTTLE (72189-395-10) 72189-395-14 14 CAPSULE in 1 BOTTLE (72189-395-14) 72189-395-20 20 CAPSULE in 1 BOTTLE (72189-395-20)

Ingredients (2)

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

Linked Drug Pages (1)

Nitrofurantoin Monohydrate/Macrocrystal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1e79886c-8ce2-c6ef-e063-6394a90a7a83", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["ee13cf2a-cde0-8ab8-e053-2a95a90a9dda"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (72189-395-10)", "package_ndc": "72189-395-10", "marketing_start_date": "20221122"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (72189-395-14)", "package_ndc": "72189-395-14", "marketing_start_date": "20221122"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (72189-395-20)", "package_ndc": "72189-395-20", "marketing_start_date": "20221122"}], "brand_name": "Nitrofurantoin Monohydrate/Macrocrystal", "product_id": "72189-395_1e79886c-8ce2-c6ef-e063-6394a90a7a83", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "72189-395", "generic_name": "Nitrofurantoin Monohydrate/Macrocrystal", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin Monohydrate/Macrocrystal", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA208516", "marketing_category": "ANDA", "marketing_start_date": "20221122", "listing_expiration_date": "20261231"}