FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
43547-566
11-digit product format
435470566
Labeler code
43547
Product ID
43547-566_d09551ff-dfac-4525-8122-97b4463e98ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare LLC
Application
ANDA077901
Marketing category
ANDA
Marketing start
2023-01-05
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
43547-566-10Clonidine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1003
43547-566-11Clonidine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-566-10EA - Each43547-5660c3d8092-1ae4-48b7-a327-131af01219c312023-06-06
43547-566-11EA - Each43547-566a034b691-8197-4f39-b30d-53b04ea3f84212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-566CLONIDINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE LLC]3Current NDC, Legacy NDC, 2 package rows20230526_2bbfea75-9241-4c3a-84f5-342ccb3cdf16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN2bbfea75-9241-4c3a-84f5-342ccb3cdf163
884173cloNIDine HCl 0.1 MG Oral TabletPSN8171776a-dd14-4dcc-8860-3c27d8ea95043
884185cloNIDine HCl 0.2 MG Oral TabletPSN2bbfea75-9241-4c3a-84f5-342ccb3cdf163
884185cloNIDine HCl 0.2 MG Oral TabletPSN8171776a-dd14-4dcc-8860-3c27d8ea95043
884189cloNIDine HCl 0.3 MG Oral TabletPSN2bbfea75-9241-4c3a-84f5-342ccb3cdf163
884173clonidine hydrochloride 0.1 MG Oral TabletSCD2bbfea75-9241-4c3a-84f5-342ccb3cdf163
884173clonidine hydrochloride 0.1 MG Oral TabletSCD8171776a-dd14-4dcc-8860-3c27d8ea95043
884185clonidine hydrochloride 0.2 MG Oral TabletSCD2bbfea75-9241-4c3a-84f5-342ccb3cdf163
884185clonidine hydrochloride 0.2 MG Oral TabletSCD8171776a-dd14-4dcc-8860-3c27d8ea95043
884189clonidine hydrochloride 0.3 MG Oral TabletSCD2bbfea75-9241-4c3a-84f5-342ccb3cdf163
884173clonidine HCl 100 MCG Oral TabletSY2bbfea75-9241-4c3a-84f5-342ccb3cdf163
884173clonidine HCl 100 MCG Oral TabletSY8171776a-dd14-4dcc-8860-3c27d8ea95043
884185clonidine HCl 200 MCG Oral TabletSY2bbfea75-9241-4c3a-84f5-342ccb3cdf163
884185clonidine HCl 200 MCG Oral TabletSY8171776a-dd14-4dcc-8860-3c27d8ea95043
884189clonidine HCl 300 MCG Oral TabletSY2bbfea75-9241-4c3a-84f5-342ccb3cdf163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-566-1043547056610100 TABLET in 1 BOTTLE, PLASTIC (43547-566-10) 100 tablet2023-01-050000-00-00NoNoCurrent
43547-566-11435470566111000 TABLET in 1 BOTTLE, PLASTIC (43547-566-11) 1000 tablet2023-01-050000-00-00NoNoCurrent