Chlorothiazide

Product NDC
63323-658
11-digit product format
633230658
Labeler code
63323
Product ID
63323-658_85e1af90-9f5e-44a1-8bc3-5868be35812b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLOROTHIAZIDE SODIUM
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA090896
Marketing category
ANDA
Marketing start
2009-10-21
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
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
63323-658-20Chlorothiazide1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,16
63323-658-20Chlorothiazide18 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,186
63323-658-94Chlorothiazide18 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,185
63323-658-94Chlorothiazide1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,15
63323-658-27Chlorothiazide18 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,184
63323-658-27Chlorothiazide1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-658-20EA - Each63323-658fbec5961-0e59-47be-be4f-4603d678c26a12012-07-24
63323-658-27EA - Each63323-658b9f9e804-f1f6-42ac-9bc9-13ee8fbeb13612013-08-02
63323-658-94EA - Each63323-658ffb91817-8004-4d5a-946c-adf54900900412013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROTHIAZIDE SODIUMACTIVE INGREDIENTSN86FG7N2KCHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
CHLOROTHIAZIDE SODIUMACTIVE INGREDIENTSN86FG7N2KCHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
CHLOROTHIAZIDE SODIUMACTIVE INGREDIENTSN86FG7N2KCHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1
CHLOROTHIAZIDEACTIVE MOIETY77W477J15HCHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
CHLOROTHIAZIDEACTIVE MOIETY77W477J15HCHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
CHLOROTHIAZIDEACTIVE MOIETY77W477J15HCHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-658CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20250409_de512e9b-444c-4ae4-8c6b-accd87a02021.zip
63323-658CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20230613_de250776-461a-4d02-a82e-ffedca1a9cf4.zip
63323-658CHLOROTHIAZIDE (CHLOROTHIAZIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20230613_5b5d8a97-1428-4047-8e6c-b778429a26e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484152chlorothiazide 500 MG InjectionPSNde512e9b-444c-4ae4-8c6b-accd87a020216
484152chlorothiazide 500 MG InjectionSCDde512e9b-444c-4ae4-8c6b-accd87a020216
484152chlorothiazide (as chlorothiazide sodium) 0.5 GM InjectionSYde512e9b-444c-4ae4-8c6b-accd87a020216
484152chlorothiazide 500 MG InjectionPSN5b5d8a97-1428-4047-8e6c-b778429a26e45
484152chlorothiazide 500 MG InjectionSCD5b5d8a97-1428-4047-8e6c-b778429a26e45
484152chlorothiazide (as chlorothiazide sodium) 0.5 GM InjectionSY5b5d8a97-1428-4047-8e6c-b778429a26e45
484152chlorothiazide 500 MG InjectionPSNde250776-461a-4d02-a82e-ffedca1a9cf44
484152chlorothiazide 500 MG InjectionSCDde250776-461a-4d02-a82e-ffedca1a9cf44
484152chlorothiazide (as chlorothiazide sodium) 0.5 GM InjectionSYde250776-461a-4d02-a82e-ffedca1a9cf44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-658-20633230658201 VIAL in 1 BOX (63323-658-20) / 18 mL in 1 VIAL1 vial2009-10-210000-00-00NoNoCurrent
63323-658-27633230658271 VIAL in 1 BOX (63323-658-27) / 18 mL in 1 VIAL1 vial2009-10-210000-00-00NoNoCurrent
63323-658-94633230658941 VIAL in 1 BOX (63323-658-94) / 18 mL in 1 VIAL1 vial2009-10-210000-00-00NoNoCurrent