nitrofurantoin (monohydrate/macrocrystals)

Generic: nitrofurantoin (monohydrate/macrocrystals)

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin (monohydrate/macrocrystals)
Generic Name nitrofurantoin (monohydrate/macrocrystals)
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-115
Product ID 82804-115_ad3c1b1b-ca8b-4976-aba5-aed2f338dd92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217357
Listing Expiration 2026-12-31
Marketing Start 2023-09-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804115
Hyphenated Format 82804-115

Supplemental Identifiers

RxCUI
1648755
UPC
0382804115143
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 ANDA217357 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (82804-115-10)
  • 14 CAPSULE in 1 BOTTLE (82804-115-14)
  • 20 CAPSULE in 1 BOTTLE (82804-115-20)
source: ndc

Packages (3)

82804-115-10 10 CAPSULE in 1 BOTTLE (82804-115-10) 82804-115-14 14 CAPSULE in 1 BOTTLE (82804-115-14) 82804-115-20 20 CAPSULE in 1 BOTTLE (82804-115-20)

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": "ad3c1b1b-ca8b-4976-aba5-aed2f338dd92", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0382804115143"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["f49f586a-79f0-4731-97f9-9aeb0839ece5"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (82804-115-10)", "package_ndc": "82804-115-10", "marketing_start_date": "20240708"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (82804-115-14)", "package_ndc": "82804-115-14", "marketing_start_date": "20240716"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (82804-115-20)", "package_ndc": "82804-115-20", "marketing_start_date": "20240724"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "82804-115_ad3c1b1b-ca8b-4976-aba5-aed2f338dd92", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "82804-115", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "Proficient Rx LP", "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": "ANDA217357", "marketing_category": "ANDA", "marketing_start_date": "20230914", "listing_expiration_date": "20261231"}