furosemide

Generic: furosemide

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name furosemide
Generic Name furosemide
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

furosemide 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-434
Product ID 68083-434_e7bd6ac5-0b85-49a8-b4a3-131d95b1764a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213902
Listing Expiration 2026-12-31
Marketing Start 2020-07-01

Pharmacologic Class

Established (EPC)
loop diuretic [epc]
Physiologic Effect
increased diuresis at loop of henle [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083434
Hyphenated Format 68083-434

Supplemental Identifiers

RxCUI
1719286 1719290 1719291
UPC
0368083434014 0368083432010 0368083433017
UNII
7LXU5N7ZO5
NUI
N0000175366 N0000175590

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 furosemide (source: ndc)
Generic Name furosemide (source: ndc)
Application Number ANDA213902 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 VIAL, GLASS in 1 BOX (68083-434-05) / 10 mL in 1 VIAL, GLASS
  • 25 VIAL, GLASS in 1 BOX (68083-434-25) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

68083-434-05 5 VIAL, GLASS in 1 BOX (68083-434-05) / 10 mL in 1 VIAL, GLASS 68083-434-25 25 VIAL, GLASS in 1 BOX (68083-434-25) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

furosemide (10 mg/mL)

Linked Drug Pages (1)

Furosemide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "e7bd6ac5-0b85-49a8-b4a3-131d95b1764a", "openfda": {"nui": ["N0000175366", "N0000175590"], "upc": ["0368083434014", "0368083432010", "0368083433017"], "unii": ["7LXU5N7ZO5"], "rxcui": ["1719286", "1719290", "1719291"], "spl_set_id": ["644704c0-e6a5-4804-bfa6-795c8f83aa7a"], "pharm_class_pe": ["Increased Diuresis at Loop of Henle [PE]"], "pharm_class_epc": ["Loop Diuretic [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, GLASS in 1 BOX (68083-434-05)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "68083-434-05", "marketing_start_date": "20200701"}, {"sample": false, "description": "25 VIAL, GLASS in 1 BOX (68083-434-25)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "68083-434-25", "marketing_start_date": "20200701"}], "brand_name": "Furosemide", "product_id": "68083-434_e7bd6ac5-0b85-49a8-b4a3-131d95b1764a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "68083-434", "generic_name": "Furosemide", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Furosemide", "active_ingredients": [{"name": "FUROSEMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA213902", "marketing_category": "ANDA", "marketing_start_date": "20200701", "listing_expiration_date": "20261231"}