FDA.reportPublic FDA data

CHLOROTHIAZIDE SODIUM

Product NDC
47335-330
11-digit product format
473350330
Labeler code
47335
Product ID
47335-330_dda0054a-e39b-4667-addf-e999a34806d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLOROTHIAZIDE SODIUM
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA091546
Marketing category
ANDA
Marketing start
2016-08-25
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6823a9b2-3fe6-2173-aeb8-21d965ee1e1eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-330-40CHLOROTHIAZIDE SODIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
47335-330-40CHLOROTHIAZIDE SODIUM18 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-330-40EA - Each47335-330bc490365-3217-44af-bef9-817571da1c9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROTHIAZIDE SODIUMACTIVE INGREDIENTSN86FG7N2KCHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]2
CHLOROTHIAZIDEACTIVE MOIETY77W477J15HCHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-330CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 2 package rows20250323_187240e9-1eed-45ec-befb-18647d175112.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484152chlorothiazide 500 MG InjectionPSN187240e9-1eed-45ec-befb-18647d1751125
484152chlorothiazide 500 MG InjectionSCD187240e9-1eed-45ec-befb-18647d1751125
484152chlorothiazide (as chlorothiazide sodium) 0.5 GM InjectionSY187240e9-1eed-45ec-befb-18647d1751125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-330-40473350330401 VIAL, SINGLE-DOSE in 1 CARTON (47335-330-40) / 18 mL in 1 VIAL, SINGLE-DOSE2016-08-250000-00-00NoNoCurrent