nitrofurantoin (monohydrate/macrocrystals)

Generic: nitrofurantoin (monohydrate/macrocrystals)

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin (monohydrate/macrocrystals)
Generic Name nitrofurantoin (monohydrate/macrocrystals)
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-195
Product ID 76420-195_e9294cf2-886b-1f04-e053-2995a90a3984
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077066
Listing Expiration 2026-12-31
Marketing Start 2005-04-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420195
Hyphenated Format 76420-195

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/macrocrystals) (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
  • 100 CAPSULE in 1 BOTTLE (76420-195-01)
  • 10 CAPSULE in 1 BOTTLE (76420-195-10)
  • 14 CAPSULE in 1 BOTTLE (76420-195-14)
  • 20 CAPSULE in 1 BOTTLE (76420-195-20)
  • 30 CAPSULE in 1 BOTTLE (76420-195-30)
  • 60 CAPSULE in 1 BOTTLE (76420-195-60)
  • 90 CAPSULE in 1 BOTTLE (76420-195-90)
source: ndc

Packages (7)

76420-195-01 100 CAPSULE in 1 BOTTLE (76420-195-01) 76420-195-10 10 CAPSULE in 1 BOTTLE (76420-195-10) 76420-195-14 14 CAPSULE in 1 BOTTLE (76420-195-14) 76420-195-20 20 CAPSULE in 1 BOTTLE (76420-195-20) 76420-195-30 30 CAPSULE in 1 BOTTLE (76420-195-30) 76420-195-60 60 CAPSULE in 1 BOTTLE (76420-195-60) 76420-195-90 90 CAPSULE in 1 BOTTLE (76420-195-90)

Ingredients (2)

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

Linked Drug Pages (1)

Nitrofurantoin (monohydrate/macrocrystals) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e9294cf2-886b-1f04-e053-2995a90a3984", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["1ab658f0-021a-46a1-bff3-d3334c23442d"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-195-01)", "package_ndc": "76420-195-01", "marketing_start_date": "20220921"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (76420-195-10)", "package_ndc": "76420-195-10", "marketing_start_date": "20211130"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (76420-195-14)", "package_ndc": "76420-195-14", "marketing_start_date": "20220921"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (76420-195-20)", "package_ndc": "76420-195-20", "marketing_start_date": "20220921"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-195-30)", "package_ndc": "76420-195-30", "marketing_start_date": "20220921"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-195-60)", "package_ndc": "76420-195-60", "marketing_start_date": "20220921"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-195-90)", "package_ndc": "76420-195-90", "marketing_start_date": "20220921"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "76420-195_e9294cf2-886b-1f04-e053-2995a90a3984", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "76420-195", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin (monohydrate/macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA077066", "marketing_category": "ANDA", "marketing_start_date": "20050406", "listing_expiration_date": "20261231"}