nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler northwind health company, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-015
Product ID 82868-015_46dc9595-3ec6-a1ad-e063-6394a90a3d15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217272
Listing Expiration 2026-12-31
Marketing Start 2023-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868015
Hyphenated Format 82868-015

Supplemental Identifiers

RxCUI
1648759
UNII
927AH8112L
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 macrocrystals (source: ndc)
Generic Name nitrofurantoin macrocrystals (source: ndc)
Application Number ANDA217272 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-10)
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-14)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-20)
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-28)
source: ndc

Packages (4)

82868-015-10 10 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-10) 82868-015-14 14 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-14) 82868-015-20 20 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-20) 82868-015-28 28 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-28)

Ingredients (1)

nitrofurantoin (100 mg/1)

Linked Drug Pages (1)

nitrofurantoin macrocrystals ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46dc9595-3ec6-a1ad-e063-6394a90a3d15", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["075fe819-fc4f-2dce-e063-6294a90ad823"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-10)", "package_ndc": "82868-015-10", "marketing_start_date": "20240208"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-14)", "package_ndc": "82868-015-14", "marketing_start_date": "20231006"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-20)", "package_ndc": "82868-015-20", "marketing_start_date": "20240604"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-28)", "package_ndc": "82868-015-28", "marketing_start_date": "20240729"}], "brand_name": "nitrofurantoin macrocrystals", "product_id": "82868-015_46dc9595-3ec6-a1ad-e063-6394a90a3d15", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "82868-015", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitrofurantoin macrocrystals", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA217272", "marketing_category": "ANDA", "marketing_start_date": "20231006", "listing_expiration_date": "20261231"}