FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
51655-353
11-digit product format
516550353
Labeler code
51655
Product ID
51655-353_48eb5573-d143-de2e-e063-6294a90a0a95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA070974
Marketing category
ANDA
Marketing start
2015-02-25
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-353-522023-04-12C16284748780-19d75b9d0-b287-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Rx only
51655-353-522020-01-31C16284748780-19d75b9d0-b287-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-353-52Clonidine Hydrochloride30 in 1 BOTTLE, DISPENSINGTABLET304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-353CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20240720_66dc3cf0-d6bd-436c-9a7f-7477575b3260.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN66dc3cf0-d6bd-436c-9a7f-7477575b32604
884173clonidine hydrochloride 0.1 MG Oral TabletSCD66dc3cf0-d6bd-436c-9a7f-7477575b32604
884173clonidine HCl 100 MCG Oral TabletSY66dc3cf0-d6bd-436c-9a7f-7477575b32604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-353-525165503535230 TABLET in 1 BOTTLE, DISPENSING (51655-353-52) 30 tablet2015-02-25NoNoCurrent