FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
0143-9723
11-digit product format
001439723
Labeler code
0143
Product ID
0143-9723_9d6244d1-5e85-4da3-b06c-f4fe8da1b6fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA200300
Marketing category
ANDA
Marketing start
2011-01-01
Substance
CLONIDINE HYDROCHLORIDE
Active strength
500 ug/mL
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE500 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884221, 884225

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9723-01Clonidine Hydrochloride10 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9723-01ML - Milliliter0143-9723381ad741-0133-471c-b325-37b51a8f503912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]2
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RCLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9723CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 1 package rows20220702_2a5b46ec-4c16-48a5-9e58-8d28a3f21274.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884221cloNIDine HCl 1000 MCG in 10 ML InjectionPSN2a5b46ec-4c16-48a5-9e58-8d28a3f212744
884225cloNIDine HCl 5000 MCG in 10 ML InjectionPSN2a5b46ec-4c16-48a5-9e58-8d28a3f212744
88422110 ML clonidine hydrochloride 0.1 MG/ML InjectionSCD2a5b46ec-4c16-48a5-9e58-8d28a3f212744
88422510 ML clonidine hydrochloride 0.5 MG/ML InjectionSCD2a5b46ec-4c16-48a5-9e58-8d28a3f212744
884221clonidine HCl 1000 MCG per 10 ML InjectionSY2a5b46ec-4c16-48a5-9e58-8d28a3f212744
884225clonidine HCl 5000 MCG per 10 ML InjectionSY2a5b46ec-4c16-48a5-9e58-8d28a3f212744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9723-010014397230110 mL in 1 VIAL, SINGLE-USE (0143-9723-01) 10 ml2011-01-010000-00-00NoNoCurrent