FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
52817-182
11-digit product format
528170182
Labeler code
52817
Product ID
52817-182_4feb108f-0b2f-75d1-e063-6394a90a6152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA070923
Marketing category
ANDA
Marketing start
2017-06-01
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.3 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.3 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
52817-182-00Clonidine hydrochloride1000 in 1 BOTTLETABLET100010
52817-182-10Clonidine hydrochloride100 in 1 BOTTLETABLET10010
52817-182-50Clonidine hydrochloride500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-182-00EA - Each52817-18210bf0a20-f2cc-402b-a0d2-75b5491bfb4f12019-02-13
52817-182-10EA - Each52817-182e804441d-f23a-4781-a567-171f655379c812017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-182CLONIDINE 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
884189cloNIDine HCl 0.3 MG Oral TabletPSNf65d90dc-11b4-4d63-b4a9-30603bc332ea100
884189clonidine hydrochloride 0.3 MG Oral TabletSCDf65d90dc-11b4-4d63-b4a9-30603bc332ea100
884189clonidine HCl 300 MCG Oral TabletSYf65d90dc-11b4-4d63-b4a9-30603bc332ea100
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
884189cloNIDine HCl 0.3 MG Oral TabletPSNf30324be-47b6-7f54-e053-2995a90a3ad42
884189clonidine hydrochloride 0.3 MG Oral TabletSCDf30324be-47b6-7f54-e053-2995a90a3ad42
884189clonidine HCl 300 MCG Oral TabletSYf30324be-47b6-7f54-e053-2995a90a3ad42
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
884189cloNIDine HCl 0.3 MG Oral TabletPSN00d1562d-b4eb-4d89-95de-0aacee7a82a51
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
884189clonidine hydrochloride 0.3 MG Oral TabletSCD00d1562d-b4eb-4d89-95de-0aacee7a82a51
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
884189clonidine HCl 300 MCG Oral TabletSY00d1562d-b4eb-4d89-95de-0aacee7a82a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-182-00528170182001000 TABLET in 1 BOTTLE (52817-182-00) 1000 tablet2017-06-010000-00-00NoNoCurrent
52817-182-1052817018210100 TABLET in 1 BOTTLE (52817-182-10) 100 tablet2017-06-010000-00-00NoNoCurrent
52817-182-5052817018250500 TABLET in 1 BOTTLE (52817-182-50) 500 tablet2017-06-010000-00-00NoNoCurrent