nitrofurantoin

Generic: nitrofurantoin

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler somerset therapeutics, llc
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

nitrofurantoin 25 mg/5mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-829
Product ID 70069-829_40efa147-f323-4d77-9a88-227434ff84c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208909
Listing Expiration 2027-12-31
Marketing Start 2025-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069829
Hyphenated Format 70069-829

Supplemental Identifiers

RxCUI
311989
UNII
927AH8112L
NUI
N0000175494 M0014892

Packaging Origin

Original Packager
true

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 (source: ndc)
Application Number ANDA208909 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (70069-829-01) / 230 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

70069-829-01 1 BOTTLE, GLASS in 1 CARTON (70069-829-01) / 230 mL in 1 BOTTLE, GLASS

Ingredients (1)

nitrofurantoin (25 mg/5mL)

Linked Drug Pages (1)

Nitrofurantoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40efa147-f323-4d77-9a88-227434ff84c3", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311989"], "spl_set_id": ["dd99ba40-edff-47c3-9ee4-7e5b7774e5b5"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (70069-829-01)  / 230 mL in 1 BOTTLE, GLASS", "package_ndc": "70069-829-01", "marketing_start_date": "20250226"}], "brand_name": "Nitrofurantoin", "product_id": "70069-829_40efa147-f323-4d77-9a88-227434ff84c3", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "70069-829", "generic_name": "Nitrofurantoin", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/5mL"}], "application_number": "ANDA208909", "marketing_category": "ANDA", "marketing_start_date": "20250226", "listing_expiration_date": "20271231"}