nitrofurantoin

Generic: nitrofurantoin

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4244
Product ID 70518-4244_4007a97b-b1fb-3acf-e063-6394a90ad7a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211935
Listing Expiration 2026-12-31
Marketing Start 2024-12-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184244
Hyphenated Format 70518-4244

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 (source: ndc)
Application Number ANDA211935 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (70518-4244-0)
source: ndc

Packages (1)

70518-4244-0 30 CAPSULE in 1 BLISTER PACK (70518-4244-0)

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": "4007a97b-b1fb-3acf-e063-6394a90ad7a1", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["87505f8f-2056-4e55-adf5-5b7309081d7c"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-4244-0)", "package_ndc": "70518-4244-0", "marketing_start_date": "20241220"}], "brand_name": "NITROFURANTOIN", "product_id": "70518-4244_4007a97b-b1fb-3acf-e063-6394a90ad7a1", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "70518-4244", "generic_name": "NITROFURANTOIN", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROFURANTOIN", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA211935", "marketing_category": "ANDA", "marketing_start_date": "20241220", "listing_expiration_date": "20261231"}