FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
83939-0005
11-digit product format
839390005
Labeler code
83939
Product ID
83939-0005_42788b2f-2fbc-d9f8-e063-6294a90aa08e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
VERITYRX, LLC
Application
ANDA091368
Marketing category
ANDA
Marketing start
2016-05-03
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
83939-0005-1clonidine hydrochloride1 in 1 POUCHTABLET11
83939-0005-2clonidine hydrochloride1 in 1 POUCHTABLET11
83939-0005-2clonidine hydrochloride50 in 1 BOX, UNIT-DOSETABLET501
83939-0005-3clonidine hydrochloride100 in 1 BOX, UNIT-DOSETABLET1001
83939-0005-3clonidine hydrochloride1 in 1 POUCHTABLET11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN42788adf-a54d-3545-e063-6394a90a8c691
884173clonidine hydrochloride 0.1 MG Oral TabletSCD42788adf-a54d-3545-e063-6394a90a8c691
884173clonidine HCl 100 MCG Oral TabletSY42788adf-a54d-3545-e063-6394a90a8c691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83939-0005-1839390005011 TABLET in 1 POUCH (83939-0005-1) 1 tablet2025-11-03NoNoHistorical
83939-0005-28393900050250 POUCH in 1 BOX, UNIT-DOSE (83939-0005-2) / 1 TABLET in 1 POUCH50 pouch2025-11-03NoNoHistorical
83939-0005-383939000503100 POUCH in 1 BOX, UNIT-DOSE (83939-0005-3) / 1 TABLET in 1 POUCH100 pouch2025-11-03NoNoHistorical