FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
52817-180
11-digit product format
528170180
Labeler code
52817
Product ID
52817-180_4feb108f-0b2f-75d1-e063-6394a90a6152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA070925
Marketing category
ANDA
Marketing start
2017-06-01
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

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
52817-180-00Clonidine hydrochloride1000 in 1 BOTTLETABLET100010
52817-180-10Clonidine hydrochloride100 in 1 BOTTLETABLET10010
52817-180-50Clonidine hydrochloride500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-180-00EA - Each52817-18054229f5a-91a3-4446-9384-04a37321508b12017-07-07
52817-180-10EA - Each52817-1806aa59267-86a8-46e0-b87a-384d92700a0712017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-180CLONIDINE HYDROCHLORIDE TABLET [TRUPHARMA, LLC]7Current NDC, Legacy NDC, 3 package rows20250102_c83e4e4f-bd0e-449d-958a-dc0d570a01ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884185cloNIDine HCl 0.2 MG Oral TabletPSNc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884189cloNIDine HCl 0.3 MG Oral TabletPSNc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
2740803cloNIDine hydrochloride 0.05 MG Oral TabletPSNc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
2740803clonidine hydrochloride 0.05 MG Oral TabletSCDc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884173clonidine hydrochloride 0.1 MG Oral TabletSCDc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884185clonidine hydrochloride 0.2 MG Oral TabletSCDc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884189clonidine hydrochloride 0.3 MG Oral TabletSCDc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884173clonidine HCl 100 MCG Oral TabletSYc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884185clonidine HCl 200 MCG Oral TabletSYc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884189clonidine HCl 300 MCG Oral TabletSYc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
2740803clonidine hydrochloride 50 MCG Oral TabletSYc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884173cloNIDine HCl 0.1 MG Oral TabletPSNcee049ea-a476-433c-971f-2466a6a3263b5
884173cloNIDine HCl 0.1 MG Oral TabletPSN7484e8fa-13a7-70e9-e053-2a91aa0a24b75
884173clonidine hydrochloride 0.1 MG Oral TabletSCD7484e8fa-13a7-70e9-e053-2a91aa0a24b75
884173clonidine hydrochloride 0.1 MG Oral TabletSCDcee049ea-a476-433c-971f-2466a6a3263b5
884173clonidine HCl 100 MCG Oral TabletSY7484e8fa-13a7-70e9-e053-2a91aa0a24b75
884173clonidine HCl 100 MCG Oral TabletSYcee049ea-a476-433c-971f-2466a6a3263b5
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
884173cloNIDine HCl 0.1 MG Oral TabletPSN33c68d5e-6a68-40fd-a326-bf36a7e01d5b2
884173clonidine hydrochloride 0.1 MG Oral TabletSCD33c68d5e-6a68-40fd-a326-bf36a7e01d5b2
884173clonidine HCl 100 MCG Oral TabletSY33c68d5e-6a68-40fd-a326-bf36a7e01d5b2
884173cloNIDine HCl 0.1 MG Oral TabletPSN50c8a725-a449-256b-e063-6294a90a3e441
884173cloNIDine HCl 0.1 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884185cloNIDine HCl 0.2 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884189cloNIDine HCl 0.3 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884173clonidine hydrochloride 0.1 MG Oral TabletSCD50c8a725-a449-256b-e063-6294a90a3e441
884173clonidine hydrochloride 0.1 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
884185clonidine hydrochloride 0.2 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
884189clonidine hydrochloride 0.3 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
884173clonidine HCl 100 MCG Oral TabletSY50c8a725-a449-256b-e063-6294a90a3e441
884173clonidine HCl 100 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61
884185clonidine HCl 200 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61
884189clonidine HCl 300 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-180-00528170180001000 TABLET in 1 BOTTLE (52817-180-00) 1000 tablet2017-06-010000-00-00NoNoCurrent
52817-180-1052817018010100 TABLET in 1 BOTTLE (52817-180-10) 100 tablet2017-06-010000-00-00NoNoCurrent
52817-180-5052817018050500 TABLET in 1 BOTTLE (52817-180-50) 500 tablet2017-06-010000-00-00NoNoCurrent