FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
55154-2576
11-digit product format
551542576
Labeler code
55154
Product ID
55154-2576_bd619b95-aedb-472f-9b42-071041fde304
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA070974
Marketing category
ANDA
Marketing start
2020-07-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.1 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
55154-2576-0Clonidine Hydrochloride10 in 1 BAGTABLET106
55154-2576-0Clonidine Hydrochloride1 in 1 BLISTER PACKTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2576CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20240726_df62817d-2f50-4c27-aaa8-a22f0290c94f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
55154-2576-05515425760010 BLISTER PACK in 1 BAG (55154-2576-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2020-07-290000-00-00NoNoCurrent