FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
71205-588
11-digit product format
712050588
Labeler code
71205
Product ID
71205-588_63ed2151-a687-4972-bbe7-f1f1ec060659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
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.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
71205-588-12Clonidine hydrochloride12 in 1 BOTTLETABLET122
71205-588-30Clonidine hydrochloride30 in 1 BOTTLETABLET302
71205-588-60Clonidine hydrochloride60 in 1 BOTTLETABLET602
71205-588-90Clonidine hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-588-12EA - Each71205-5887e09ae77-6ae3-420a-8546-2b43e214f0de12021-10-08
71205-588-30EA - Each71205-58866bb21c9-0b8a-4e68-80f6-ad97d394f22112022-12-07
71205-588-60EA - Each71205-588615f1b6d-2b2f-496f-ab1d-7d5837681e7512026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-588CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20220930_33c68d5e-6a68-40fd-a326-bf36a7e01d5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-588-127120505881212 TABLET in 1 BOTTLE (71205-588-12) 12 tablet2021-07-070000-00-00NoNoCurrent
71205-588-307120505883030 TABLET in 1 BOTTLE (71205-588-30) 30 tablet2021-07-070000-00-00NoNoCurrent
71205-588-607120505886060 TABLET in 1 BOTTLE (71205-588-60) 60 tablet2021-07-070000-00-00NoNoCurrent
71205-588-907120505889090 TABLET in 1 BOTTLE (71205-588-90) 90 tablet2021-07-070000-00-00NoNoCurrent