FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
0228-2127
11-digit product format
002282127
Labeler code
0228
Product ID
0228-2127_860129c9-0bba-471e-a90c-b6bede1833b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070974
Marketing category
ANDA
Marketing start
1995-01-03
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 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.1 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
0228-2127-10Clonidine Hydrochloride100 in 1 BOTTLETABLET10018
0228-2127-50Clonidine Hydrochloride500 in 1 BOTTLETABLET50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2127-10EA - Each0228-212716a5e27a-ac7b-43e3-a511-247382bf3ae312012-07-24
0228-2127-50EA - Each0228-2127114663e9-55ac-4061-bd5b-746b5e41bfa912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
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 (CLONIDINE HCL) TABLET [STAT RX USA LLC]2
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE (CLONIDINE HCL) TABLET [STAT RX USA LLC]2
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]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
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]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
0228-2127CLONIDINE 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
884173cloNIDine HCl 0.1 MG Oral TabletPSN0bde4636-7f34-467e-b9b9-8d281145177d25
884173clonidine hydrochloride 0.1 MG Oral TabletSCD0bde4636-7f34-467e-b9b9-8d281145177d25
884173clonidine HCl 100 MCG Oral TabletSY0bde4636-7f34-467e-b9b9-8d281145177d25
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
884173cloNIDine HCl 0.1 MG Oral TabletPSN9aacff76-c606-45b3-93b5-92eda17303ef11
884173clonidine hydrochloride 0.1 MG Oral TabletSCD9aacff76-c606-45b3-93b5-92eda17303ef11
884173clonidine HCl 100 MCG Oral TabletSY9aacff76-c606-45b3-93b5-92eda17303ef11
884173cloNIDine HCl 0.1 MG Oral TabletPSN7cd64137-09d7-7a00-e053-2a91aa0a06ae6
884173clonidine hydrochloride 0.1 MG Oral TabletSCD7cd64137-09d7-7a00-e053-2a91aa0a06ae6
884173clonidine HCl 100 MCG Oral TabletSY7cd64137-09d7-7a00-e053-2a91aa0a06ae6
884173cloNIDine HCl 0.1 MG Oral TabletPSN639398cd-3d6a-43d8-93d6-9abecab9d7485
884173clonidine hydrochloride 0.1 MG Oral TabletSCD639398cd-3d6a-43d8-93d6-9abecab9d7485
884173clonidine HCl 100 MCG Oral TabletSY639398cd-3d6a-43d8-93d6-9abecab9d7485
884173cloNIDine HCl 0.1 MG Oral TabletPSN785f0671-13ba-05f6-e053-2a91aa0a0ec44
884173cloNIDine HCl 0.1 MG Oral TabletPSN66dc3cf0-d6bd-436c-9a7f-7477575b32604
884173clonidine hydrochloride 0.1 MG Oral TabletSCD66dc3cf0-d6bd-436c-9a7f-7477575b32604
884173clonidine hydrochloride 0.1 MG Oral TabletSCD785f0671-13ba-05f6-e053-2a91aa0a0ec44
884173clonidine HCl 100 MCG Oral TabletSY66dc3cf0-d6bd-436c-9a7f-7477575b32604
884173clonidine HCl 100 MCG Oral TabletSY785f0671-13ba-05f6-e053-2a91aa0a0ec44
884173cloNIDine HCl 0.1 MG Oral TabletPSN531eb107-a0bf-4346-946c-18715ca225183
884173cloNIDine HCl 0.1 MG Oral TabletPSNe6583ff5-0e03-470b-a986-35770aa0e80b3
884173clonidine hydrochloride 0.1 MG Oral TabletSCD531eb107-a0bf-4346-946c-18715ca225183
884173clonidine hydrochloride 0.1 MG Oral TabletSCDe6583ff5-0e03-470b-a986-35770aa0e80b3
884173clonidine HCl 100 MCG Oral TabletSYe6583ff5-0e03-470b-a986-35770aa0e80b3
884173clonidine HCl 100 MCG Oral TabletSY531eb107-a0bf-4346-946c-18715ca225183
884173cloNIDine HCl 0.1 MG Oral TabletPSN438dece9-95d4-40f2-84b4-9e2c6d88e7602
884173cloNIDine HCl 0.1 MG Oral TabletPSNdf4b087e-a81a-1321-e053-2995a90a2b9f2
884173clonidine hydrochloride 0.1 MG Oral TabletSCDdf4b087e-a81a-1321-e053-2995a90a2b9f2
884173clonidine hydrochloride 0.1 MG Oral TabletSCD438dece9-95d4-40f2-84b4-9e2c6d88e7602
884173clonidine HCl 100 MCG Oral TabletSY438dece9-95d4-40f2-84b4-9e2c6d88e7602
884173clonidine HCl 100 MCG Oral TabletSYdf4b087e-a81a-1321-e053-2995a90a2b9f2
884173cloNIDine HCl 0.1 MG Oral TabletPSN5a43b329-7dd6-b479-e053-2991aa0a7d831
884173cloNIDine HCl 0.1 MG Oral TabletPSN2c04fc9b-5f83-4a3a-87e3-2b07affd0ad01
884173cloNIDine HCl 0.1 MG Oral TabletPSNc2f1cbfd-54ec-469c-b535-d1df5a11a8281
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 TabletSCDc2f1cbfd-54ec-469c-b535-d1df5a11a8281
884173clonidine hydrochloride 0.1 MG Oral TabletSCD2c04fc9b-5f83-4a3a-87e3-2b07affd0ad01
884173clonidine hydrochloride 0.1 MG Oral TabletSCD091a191f-4380-4960-834c-0618da7384031
884173clonidine hydrochloride 0.1 MG Oral TabletSCD5a43b329-7dd6-b479-e053-2991aa0a7d831
884185clonidine hydrochloride 0.2 MG Oral TabletSCD091a191f-4380-4960-834c-0618da7384031
884173clonidine HCl 100 MCG Oral TabletSYc2f1cbfd-54ec-469c-b535-d1df5a11a8281
884173clonidine HCl 100 MCG Oral TabletSY091a191f-4380-4960-834c-0618da7384031
884173clonidine HCl 100 MCG Oral TabletSY2c04fc9b-5f83-4a3a-87e3-2b07affd0ad01
884173clonidine HCl 100 MCG Oral TabletSY5a43b329-7dd6-b479-e053-2991aa0a7d831
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
0228-2127-1000228212710100 TABLET in 1 BOTTLE (0228-2127-10) 100 tablet1995-01-030000-00-00NoNoCurrent
0228-2127-5000228212750500 TABLET in 1 BOTTLE (0228-2127-50) 500 tablet1995-01-030000-00-00NoNoCurrent