FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
60687-124
11-digit product format
606870124
Labeler code
60687
Product ID
60687-124_16c59ca8-fc05-de71-e063-6294a90ab3fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA070975
Marketing category
ANDA
Marketing start
2020-07-30
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

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
60687-124-01Clonidine Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1007
60687-124-11Clonidine Hydrochloride1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-124-01EA - Each60687-124b15b2eb5-ddf9-4d92-a8a1-ab46ac2f7cd512020-08-06
60687-124-11EA - Each60687-12452ea308a-0dd8-4172-957b-50ec40b1ed6712020-08-06

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-124CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20240522_b4733c99-656d-4049-9422-3732492dd6ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
884173cloNIDine HCl 0.1 MG Oral TabletPSNdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884185cloNIDine HCl 0.2 MG Oral TabletPSNdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884173clonidine hydrochloride 0.1 MG Oral TabletSCDdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884185clonidine hydrochloride 0.2 MG Oral TabletSCDdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884173clonidine HCl 100 MCG Oral TabletSYdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884185clonidine HCl 200 MCG Oral TabletSYdf62817d-2f50-4c27-aaa8-a22f0290c94f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-124-0160687012401100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-124-01) / 1 TABLET in 1 BLISTER PACK (60687-124-11) 100 blister pack2020-07-300000-00-00NoNoCurrent
60687-124-11606870124111 in 1 BLISTER PACKHistorical