Chlorothiazide sodium

Product NDC
68083-614
11-digit product format
680830614
Labeler code
68083
Product ID
68083-614_e19fe503-9b2e-4db0-b4ee-0fb9ec9c11c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorothiazide sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA218630
Marketing category
ANDA
Marketing start
2024-10-03
Substance
CHLOROTHIAZIDE SODIUM
Active strength
500 mg/18mL
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data

Finished product
Yes
Brand name base
Chlorothiazide sodium
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
CHLOROTHIAZIDE SODIUM500 mg/18mL

Harmonized Identifiers

FieldValues
UniiSN86FG7N2K
Rxcui484152

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
SN86FG7N2KCHLOROTHIAZIDE SODIUM7085-44-1CHLOROTHIAZIDE SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-614-01680830614011 VIAL in 1 CARTON (68083-614-01) / 18 mL in 1 VIAL1 vial2024-10-03NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Chlorothiazide Sodium for Injection, USP Rx OnlyGland Pharma Limited2024-10-07Human Prescription Drug Label3