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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROTHIAZIDE SODIUM500 mg/18mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSN86FG7N2K
Rxcui484152

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d305018-7d41-42ea-a6eb-85f5b05f9a63Product name320250429
6823a9b2-3fe6-2173-aeb8-21d965ee1e1eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-614-01Chlorothiazide sodium18 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,183
68083-614-01Chlorothiazide sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-614CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]3Current NDC, 2 package rows20241010_bf921935-9740-458e-b786-69f76d8ad139.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484152chlorothiazide 500 MG InjectionPSNbf921935-9740-458e-b786-69f76d8ad1393
484152chlorothiazide 500 MG InjectionSCDbf921935-9740-458e-b786-69f76d8ad1393
484152chlorothiazide (as chlorothiazide sodium) 0.5 GM InjectionSYbf921935-9740-458e-b786-69f76d8ad1393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-614-01680830614011 VIAL in 1 CARTON (68083-614-01) / 18 mL in 1 VIAL1 vial2024-10-03NoNoCurrent