FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
68001-238
11-digit product format
680010238
Labeler code
68001
Product ID
68001-238_42c4b1f4-a2c5-e21f-e063-6294a90aa481
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
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
68001-238-00Clonidine Hydrochloride100 in 1 BOTTLETABLET10015
68001-238-03Clonidine Hydrochloride500 in 1 BOTTLETABLET50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-238-00EA - Each68001-23885ad3c6c-070f-4083-9a66-dfb63fef7b0712014-04-03
68001-238-03EA - Each68001-238a8873df4-131d-4702-a7a9-c9498d06a2f112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-238CLONIDINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]14Current NDC, Legacy NDC, 2 package rows20231122_1ea412db-d847-4094-be83-e3bd7328537a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN1ea412db-d847-4094-be83-e3bd7328537a15
884185cloNIDine HCl 0.2 MG Oral TabletPSN1ea412db-d847-4094-be83-e3bd7328537a15
884189cloNIDine HCl 0.3 MG Oral TabletPSN1ea412db-d847-4094-be83-e3bd7328537a15
884173clonidine hydrochloride 0.1 MG Oral TabletSCD1ea412db-d847-4094-be83-e3bd7328537a15
884185clonidine hydrochloride 0.2 MG Oral TabletSCD1ea412db-d847-4094-be83-e3bd7328537a15
884189clonidine hydrochloride 0.3 MG Oral TabletSCD1ea412db-d847-4094-be83-e3bd7328537a15
884173clonidine HCl 100 MCG Oral TabletSY1ea412db-d847-4094-be83-e3bd7328537a15
884185clonidine HCl 200 MCG Oral TabletSY1ea412db-d847-4094-be83-e3bd7328537a15
884189clonidine HCl 300 MCG Oral TabletSY1ea412db-d847-4094-be83-e3bd7328537a15
884173cloNIDine HCl 0.1 MG Oral TabletPSNb4733c99-656d-4049-9422-3732492dd6ed7
884185cloNIDine HCl 0.2 MG Oral TabletPSNb4733c99-656d-4049-9422-3732492dd6ed7
884173clonidine hydrochloride 0.1 MG Oral TabletSCDb4733c99-656d-4049-9422-3732492dd6ed7
884185clonidine hydrochloride 0.2 MG Oral TabletSCDb4733c99-656d-4049-9422-3732492dd6ed7
884173clonidine HCl 100 MCG Oral TabletSYb4733c99-656d-4049-9422-3732492dd6ed7
884185clonidine HCl 200 MCG Oral TabletSYb4733c99-656d-4049-9422-3732492dd6ed7
884185cloNIDine HCl 0.2 MG Oral TabletPSN266af0b1-ce85-6699-e063-6394a90acb4d2
884185clonidine hydrochloride 0.2 MG Oral TabletSCD266af0b1-ce85-6699-e063-6394a90acb4d2
884185clonidine HCl 200 MCG Oral TabletSY266af0b1-ce85-6699-e063-6394a90acb4d2
884185cloNIDine HCl 0.2 MG Oral TabletPSN4b889e12-0382-4679-9cec-d6829c59e8531
884185clonidine hydrochloride 0.2 MG Oral TabletSCD4b889e12-0382-4679-9cec-d6829c59e8531
884185clonidine HCl 200 MCG Oral TabletSY4b889e12-0382-4679-9cec-d6829c59e8531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-238-0068001023800100 TABLET in 1 BOTTLE (68001-238-00) 100 tablet1995-01-030000-00-00NoNoCurrent
68001-238-0368001023803500 TABLET in 1 BOTTLE (68001-238-03) 500 tablet1995-01-030000-00-00NoNoCurrent