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

openFDA Listing Details

Product ID: 68083-614_e19fe503-9b2e-4db0-b4ee-0fb9ec9c11c2
SPL ID: e19fe503-9b2e-4db0-b4ee-0fb9ec9c11c2
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Chlorothiazide sodium
Generic name: Chlorothiazide sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Marketing start: 2024-10-03
Marketing category: ANDA
Application number: ANDA218630
Pharmacologic classes: Increased Diuresis [PE]; Thiazide Diuretic [EPC]; Thiazides [CS]
Listing expiration: 2026-12-31

Ingredient	Strength
CHLOROTHIAZIDE SODIUM	500 mg/18mL

Package NDC	Description	Marketing start	Sample
68083-614-01	1 VIAL in 1 CARTON (68083-614-01) / 18 mL in 1 VIAL	2024-10-03	No

UNII	Preferred term	Registry number	Matched term
SN86FG7N2K	CHLOROTHIAZIDE SODIUM	7085-44-1	CHLOROTHIAZIDE SODIUM

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68083-614-01	68083061401	1 VIAL in 1 CARTON (68083-614-01) / 18 mL in 1 VIAL	1 vial	2024-10-03	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Chlorothiazide Sodium for Injection, USP Rx Only	Gland Pharma Limited	2024-10-07	Human Prescription Drug Label	3