nitrofurantoin

Generic: nitrofurantoin macrocrystals

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin macrocrystals
Labeler a-s medication solutions
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7217
Product ID 50090-7217_bb60450d-7bb5-434e-b1d5-23d653a1c2fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217272
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907217
Hyphenated Format 50090-7217

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 (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
  • 28 CAPSULE in 1 BOTTLE (50090-7217-0)
  • 20 CAPSULE in 1 BOTTLE (50090-7217-2)
  • 14 CAPSULE in 1 BOTTLE (50090-7217-3)
source: ndc

Packages (3)

50090-7217-0 28 CAPSULE in 1 BOTTLE (50090-7217-0) 50090-7217-2 20 CAPSULE in 1 BOTTLE (50090-7217-2) 50090-7217-3 14 CAPSULE in 1 BOTTLE (50090-7217-3)

Ingredients (1)

nitrofurantoin (100 mg/1)

Linked Drug Pages (1)

nitrofurantoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bb60450d-7bb5-434e-b1d5-23d653a1c2fa", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["4cd9e234-a2b9-4201-b8f8-cf37c0672de7"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (50090-7217-0)", "package_ndc": "50090-7217-0", "marketing_start_date": "20240812"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (50090-7217-2)", "package_ndc": "50090-7217-2", "marketing_start_date": "20240812"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (50090-7217-3)", "package_ndc": "50090-7217-3", "marketing_start_date": "20240812"}], "brand_name": "nitrofurantoin", "product_id": "50090-7217_bb60450d-7bb5-434e-b1d5-23d653a1c2fa", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "50090-7217", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA217272", "marketing_category": "ANDA", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}