nitrofurantion

Generic: nitrofurantion

Labeler: bluepoint labortories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantion
Generic Name nitrofurantion
Labeler bluepoint labortories
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 50 mg/1

Manufacturer
BluePoint Labortories

Identifiers & Regulatory

Product NDC 68001-385
Product ID 68001-385_ad020393-1c97-49da-b0f3-d6a9359fb73d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201722
Listing Expiration 2026-12-31
Marketing Start 2019-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001385
Hyphenated Format 68001-385

Supplemental Identifiers

RxCUI
311994 311995 1648759
UPC
0368001385008 0368001386005
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 nitrofurantion (source: ndc)
Generic Name nitrofurantion (source: ndc)
Application Number ANDA201722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68001-385-00)
source: ndc

Packages (1)

68001-385-00 100 CAPSULE in 1 BOTTLE (68001-385-00)

Ingredients (1)

nitrofurantoin (50 mg/1)

Linked Drug Pages (1)

Nitrofurantion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ad020393-1c97-49da-b0f3-d6a9359fb73d", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0368001385008", "0368001386005"], "unii": ["927AH8112L"], "rxcui": ["311994", "311995", "1648759"], "spl_set_id": ["ad020393-1c97-49da-b0f3-d6a9359fb73d"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["BluePoint Labortories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68001-385-00)", "package_ndc": "68001-385-00", "marketing_start_date": "20190514"}], "brand_name": "Nitrofurantion", "product_id": "68001-385_ad020393-1c97-49da-b0f3-d6a9359fb73d", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "68001-385", "generic_name": "Nitrofurantion", "labeler_name": "BluePoint Labortories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantion", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "50 mg/1"}], "application_number": "ANDA201722", "marketing_category": "ANDA", "marketing_start_date": "20190514", "listing_expiration_date": "20261231"}