FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
71335-1495
11-digit product format
713351495
Labeler code
71335
Product ID
71335-1495_849d5b92-8342-4f52-b280-d0838716a4f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091368
Marketing category
ANDA
Marketing start
2016-05-03
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
Rxcui884185

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
71335-1495-1clonidine hydrochloride30 in 1 BOTTLETABLET30102
71335-1495-2clonidine hydrochloride60 in 1 BOTTLETABLET60102
71335-1495-3clonidine hydrochloride100 in 1 BOTTLETABLET100102
71335-1495-4clonidine hydrochloride90 in 1 BOTTLETABLET90102
71335-1495-5clonidine hydrochloride120 in 1 BOTTLETABLET120102
71335-1495-6clonidine hydrochloride14 in 1 BOTTLETABLET14102
71335-1495-7clonidine hydrochloride15 in 1 BOTTLETABLET15102
71335-1495-8clonidine hydrochloride20 in 1 BOTTLETABLET20102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1495CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 8 package rows20250402_100a31f2-9a8e-4245-a09c-05583c3244c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSN100a31f2-9a8e-4245-a09c-05583c3244c3102
884185clonidine hydrochloride 0.2 MG Oral TabletSCD100a31f2-9a8e-4245-a09c-05583c3244c3102
884185clonidine HCl 200 MCG Oral TabletSY100a31f2-9a8e-4245-a09c-05583c3244c3102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1495-17133514950130 TABLET in 1 BOTTLE (71335-1495-1) 30 tablet2022-02-090000-00-00NoNoCurrent
71335-1495-27133514950260 TABLET in 1 BOTTLE (71335-1495-2) 60 tablet2022-02-090000-00-00NoNoCurrent
71335-1495-371335149503100 TABLET in 1 BOTTLE (71335-1495-3) 100 tablet2022-02-090000-00-00NoNoCurrent
71335-1495-47133514950490 TABLET in 1 BOTTLE (71335-1495-4) 90 tablet2022-02-090000-00-00NoNoCurrent
71335-1495-571335149505120 TABLET in 1 BOTTLE (71335-1495-5) 120 tablet2022-02-090000-00-00NoNoCurrent
71335-1495-67133514950614 TABLET in 1 BOTTLE (71335-1495-6) 14 tablet2022-02-090000-00-00NoNoCurrent
71335-1495-77133514950715 TABLET in 1 BOTTLE (71335-1495-7) 15 tablet2022-02-090000-00-00NoNoCurrent
71335-1495-87133514950820 TABLET in 1 BOTTLE (71335-1495-8) 20 tablet2022-02-090000-00-00NoNoCurrent