Nitrofurantoin (monohydrate/macrocrystals)

Generic: Nitrofurantoin monohydrate/macrocrystals

Labeler: AvPAK
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Nitrofurantoin (monohydrate/macrocrystals)
Generic Name Nitrofurantoin monohydrate/macrocrystals
Labeler AvPAK
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

NITROFURANTOIN 25 mg/1, NITROFURANTOIN MONOHYDRATE 75 mg/1

Identifiers & Regulatory

Product NDC 50268-625
Product ID 50268-625_47e7e0a3-3d3c-80c0-e063-6294a90a9771
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207372
Marketing Start 2018-08-15
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268625
Hyphenated Format 50268-625

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 ANDA207372 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-625-15) / 1 CAPSULE in 1 BLISTER PACK (50268-625-11)
source: ndc

Packages (1)

50268-625-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-625-15) / 1 CAPSULE in 1 BLISTER PACK (50268-625-11)

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": "47e7e0a3-3d3c-80c0-e063-6294a90a9771", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["736b2487-e83f-d172-e053-2a91aa0ab0cf"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-625-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-625-11)", "package_ndc": "50268-625-15", "marketing_end_date": "20260228", "marketing_start_date": "20180815"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "50268-625_47e7e0a3-3d3c-80c0-e063-6294a90a9771", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "50268-625", "generic_name": "Nitrofurantoin monohydrate/macrocrystals", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "brand_name_suffix": "(monohydrate/macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA207372", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20180815"}