FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
0228-2128
11-digit product format
002282128
Labeler code
0228
Product ID
0228-2128_860129c9-0bba-471e-a90c-b6bede1833b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070975
Marketing category
ANDA
Marketing start
1995-01-03
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.2 mg/1
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 HYDROCHLORIDE.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173, 884185, 884189

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
0228-2128-10Clonidine Hydrochloride100 in 1 BOTTLETABLET10018
0228-2128-50Clonidine Hydrochloride500 in 1 BOTTLETABLET50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2128-10EA - Each0228-2128aa557362-c8c8-45d3-b4c5-b26bbb1ccd8312012-07-24
0228-2128-50EA - Each0228-21284a21bad9-93f7-4425-be20-0da7b362078712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2128CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]17Current NDC, Legacy NDC, 2 package rows20231216_a842ab83-3531-44dd-a8a8-64dd89e87026.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSN2e4802eb-c08b-45a2-a222-b0af5db88c7a19
884185clonidine hydrochloride 0.2 MG Oral TabletSCD2e4802eb-c08b-45a2-a222-b0af5db88c7a19
884185clonidine HCl 200 MCG Oral TabletSY2e4802eb-c08b-45a2-a222-b0af5db88c7a19
884173cloNIDine HCl 0.1 MG Oral TabletPSNa842ab83-3531-44dd-a8a8-64dd89e8702618
884185cloNIDine HCl 0.2 MG Oral TabletPSNa842ab83-3531-44dd-a8a8-64dd89e8702618
884189cloNIDine HCl 0.3 MG Oral TabletPSNa842ab83-3531-44dd-a8a8-64dd89e8702618
884173clonidine hydrochloride 0.1 MG Oral TabletSCDa842ab83-3531-44dd-a8a8-64dd89e8702618
884185clonidine hydrochloride 0.2 MG Oral TabletSCDa842ab83-3531-44dd-a8a8-64dd89e8702618
884189clonidine hydrochloride 0.3 MG Oral TabletSCDa842ab83-3531-44dd-a8a8-64dd89e8702618
884173clonidine HCl 100 MCG Oral TabletSYa842ab83-3531-44dd-a8a8-64dd89e8702618
884185clonidine HCl 200 MCG Oral TabletSYa842ab83-3531-44dd-a8a8-64dd89e8702618
884189clonidine HCl 300 MCG Oral TabletSYa842ab83-3531-44dd-a8a8-64dd89e8702618
884185cloNIDine HCl 0.2 MG Oral TabletPSN86e3f9d8-83ed-4ade-bc25-b56d8e223b8b10
884185clonidine hydrochloride 0.2 MG Oral TabletSCD86e3f9d8-83ed-4ade-bc25-b56d8e223b8b10
884185clonidine HCl 200 MCG Oral TabletSY86e3f9d8-83ed-4ade-bc25-b56d8e223b8b10
884185cloNIDine HCl 0.2 MG Oral TabletPSN18c873b1-f2fe-4ba9-b384-38e917af373b3
884185cloNIDine HCl 0.2 MG Oral TabletPSN37222162-9679-482b-b9e1-d95c763352d63
884185clonidine hydrochloride 0.2 MG Oral TabletSCD18c873b1-f2fe-4ba9-b384-38e917af373b3
884185clonidine hydrochloride 0.2 MG Oral TabletSCD37222162-9679-482b-b9e1-d95c763352d63
884185clonidine HCl 200 MCG Oral TabletSY18c873b1-f2fe-4ba9-b384-38e917af373b3
884185clonidine HCl 200 MCG Oral TabletSY37222162-9679-482b-b9e1-d95c763352d63
884185cloNIDine HCl 0.2 MG Oral TabletPSNbcce548d-7ab9-74b1-e053-2995a90a71002
884185clonidine hydrochloride 0.2 MG Oral TabletSCDbcce548d-7ab9-74b1-e053-2995a90a71002
884185clonidine HCl 200 MCG Oral TabletSYbcce548d-7ab9-74b1-e053-2995a90a71002
884173cloNIDine HCl 0.1 MG Oral TabletPSN091a191f-4380-4960-834c-0618da7384031
884185cloNIDine HCl 0.2 MG Oral TabletPSN091a191f-4380-4960-834c-0618da7384031
884173clonidine hydrochloride 0.1 MG Oral TabletSCD091a191f-4380-4960-834c-0618da7384031
884185clonidine hydrochloride 0.2 MG Oral TabletSCD091a191f-4380-4960-834c-0618da7384031
884173clonidine HCl 100 MCG Oral TabletSY091a191f-4380-4960-834c-0618da7384031
884185clonidine HCl 200 MCG Oral TabletSY091a191f-4380-4960-834c-0618da7384031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-2128-1000228212810100 TABLET in 1 BOTTLE (0228-2128-10) 100 tablet1995-01-030000-00-00NoNoCurrent
0228-2128-5000228212850500 TABLET in 1 BOTTLE (0228-2128-50) 500 tablet1995-01-030000-00-00NoNoCurrent