FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
51655-445
11-digit product format
516550445
Labeler code
51655
Product ID
51655-445_490edb25-d3c2-8b45-e063-6394a90a9bc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA070925
Marketing category
ANDA
Marketing start
2020-10-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-445-18Clonidine hydrochloride180 in 1 BOTTLE, PLASTICTABLET1803
51655-445-25Clonidine hydrochloride60 in 1 BOTTLE, PLASTICTABLET603
51655-445-26Clonidine hydrochloride90 in 1 BOTTLE, PLASTICTABLET903
51655-445-52Clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-445CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2Current NDC, 4 package rows20240627_df603f27-d341-3957-e053-2995a90a825f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNdf603f27-d341-3957-e053-2995a90a825f3
884173clonidine hydrochloride 0.1 MG Oral TabletSCDdf603f27-d341-3957-e053-2995a90a825f3
884173clonidine HCl 100 MCG Oral TabletSYdf603f27-d341-3957-e053-2995a90a825f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-445-1851655044518180 TABLET in 1 BOTTLE, PLASTIC (51655-445-18) 180 tablet2022-03-23NoNoCurrent
51655-445-255165504452560 TABLET in 1 BOTTLE, PLASTIC (51655-445-25) 60 tablet2022-08-26NoNoCurrent
51655-445-265165504452690 TABLET in 1 BOTTLE, PLASTIC (51655-445-26) 90 tablet2024-03-05NoNoCurrent
51655-445-525165504455230 TABLET in 1 BOTTLE, PLASTIC (51655-445-52) 30 tablet2020-10-01NoNoCurrent