chlorothiazide sodium

Generic: chlorothiazide sodium

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

Drug Facts

Product Profile

Brand Name chlorothiazide sodium
Generic Name chlorothiazide sodium
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

chlorothiazide sodium 500 mg/18mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-614
Product ID 68083-614_e19fe503-9b2e-4db0-b4ee-0fb9ec9c11c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218630
Listing Expiration 2026-12-31
Marketing Start 2024-10-03

Pharmacologic Class

Classes
increased diuresis [pe] thiazide diuretic [epc] thiazides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083614
Hyphenated Format 68083-614

Supplemental Identifiers

RxCUI
484152
UPC
0368083614010
UNII
SN86FG7N2K

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 chlorothiazide sodium (source: ndc)
Generic Name chlorothiazide sodium (source: ndc)
Application Number ANDA218630 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/18mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-614-01) / 18 mL in 1 VIAL
source: ndc

Packages (1)

68083-614-01 1 VIAL in 1 CARTON (68083-614-01) / 18 mL in 1 VIAL

Ingredients (1)

chlorothiazide sodium (500 mg/18mL)

Linked Drug Pages (1)

Chlorothiazide sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e19fe503-9b2e-4db0-b4ee-0fb9ec9c11c2", "openfda": {"upc": ["0368083614010"], "unii": ["SN86FG7N2K"], "rxcui": ["484152"], "spl_set_id": ["bf921935-9740-458e-b786-69f76d8ad139"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-614-01)  / 18 mL in 1 VIAL", "package_ndc": "68083-614-01", "marketing_start_date": "20241003"}], "brand_name": "Chlorothiazide sodium", "product_id": "68083-614_e19fe503-9b2e-4db0-b4ee-0fb9ec9c11c2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "68083-614", "generic_name": "Chlorothiazide sodium", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorothiazide sodium", "active_ingredients": [{"name": "CHLOROTHIAZIDE SODIUM", "strength": "500 mg/18mL"}], "application_number": "ANDA218630", "marketing_category": "ANDA", "marketing_start_date": "20241003", "listing_expiration_date": "20261231"}