FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
71335-2692
11-digit product format
713352692
Labeler code
71335
Product ID
71335-2692_4082d9a5-6176-484a-ab83-d49589a6e286
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202297
Marketing category
ANDA
Marketing start
2020-07-01
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
71335-2692-1Clonidine Hydrochloride30 in 1 BOTTLETABLET301
71335-2692-2Clonidine Hydrochloride60 in 1 BOTTLETABLET601
71335-2692-3Clonidine Hydrochloride100 in 1 BOTTLETABLET1001
71335-2692-4Clonidine Hydrochloride90 in 1 BOTTLETABLET901
71335-2692-5Clonidine Hydrochloride120 in 1 BOTTLETABLET1201
71335-2692-6Clonidine Hydrochloride14 in 1 BOTTLETABLET141
71335-2692-7Clonidine Hydrochloride15 in 1 BOTTLETABLET151
71335-2692-8Clonidine Hydrochloride20 in 1 BOTTLETABLET201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSN5bc6188d-5b51-4dee-a12d-f2d5e42eb88d1
884185clonidine hydrochloride 0.2 MG Oral TabletSCD5bc6188d-5b51-4dee-a12d-f2d5e42eb88d1
884185clonidine HCl 200 MCG Oral TabletSY5bc6188d-5b51-4dee-a12d-f2d5e42eb88d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2692-17133526920130 TABLET in 1 BOTTLE (71335-2692-1) 30 tablet2025-09-18NoNoHistorical
71335-2692-27133526920260 TABLET in 1 BOTTLE (71335-2692-2) 60 tablet2025-09-18NoNoHistorical
71335-2692-371335269203100 TABLET in 1 BOTTLE (71335-2692-3) 100 tablet2025-09-18NoNoHistorical
71335-2692-47133526920490 TABLET in 1 BOTTLE (71335-2692-4) 90 tablet2025-09-18NoNoHistorical
71335-2692-571335269205120 TABLET in 1 BOTTLE (71335-2692-5) 120 tablet2025-09-18NoNoHistorical
71335-2692-67133526920614 TABLET in 1 BOTTLE (71335-2692-6) 14 tablet2025-09-18NoNoHistorical
71335-2692-77133526920715 TABLET in 1 BOTTLE (71335-2692-7) 15 tablet2025-09-18NoNoHistorical
71335-2692-87133526920820 TABLET in 1 BOTTLE (71335-2692-8) 20 tablet2025-09-18NoNoHistorical