FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
71335-3028
11-digit product format
713353028
Labeler code
71335
Product ID
71335-3028_33a25cc7-8de5-46f1-9fc8-702f26faa367
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070924
Marketing category
ANDA
Marketing start
2017-06-01
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
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.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
71335-3028-1Clonidine hydrochloride30 in 1 BOTTLETABLET30101
71335-3028-2Clonidine hydrochloride60 in 1 BOTTLETABLET60101
71335-3028-3Clonidine hydrochloride100 in 1 BOTTLETABLET100101
71335-3028-4Clonidine hydrochloride90 in 1 BOTTLETABLET90101
71335-3028-5Clonidine hydrochloride120 in 1 BOTTLETABLET120101
71335-3028-6Clonidine hydrochloride14 in 1 BOTTLETABLET14101
71335-3028-7Clonidine hydrochloride15 in 1 BOTTLETABLET15101
71335-3028-8Clonidine hydrochloride20 in 1 BOTTLETABLET20101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSNa32f4b18-1090-4d79-a56b-39c0cf366bbc101
884185clonidine hydrochloride 0.2 MG Oral TabletSCDa32f4b18-1090-4d79-a56b-39c0cf366bbc101
884185clonidine HCl 200 MCG Oral TabletSYa32f4b18-1090-4d79-a56b-39c0cf366bbc101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3028-17133530280130 TABLET in 1 BOTTLE (71335-3028-1) 30 tablet2026-02-05NoNoHistorical
71335-3028-27133530280260 TABLET in 1 BOTTLE (71335-3028-2) 60 tablet2026-02-05NoNoHistorical
71335-3028-371335302803100 TABLET in 1 BOTTLE (71335-3028-3) 100 tablet2026-02-05NoNoHistorical
71335-3028-47133530280490 TABLET in 1 BOTTLE (71335-3028-4) 90 tablet2026-02-05NoNoHistorical
71335-3028-571335302805120 TABLET in 1 BOTTLE (71335-3028-5) 120 tablet2026-02-05NoNoHistorical
71335-3028-67133530280614 TABLET in 1 BOTTLE (71335-3028-6) 14 tablet2026-02-05NoNoHistorical
71335-3028-77133530280715 TABLET in 1 BOTTLE (71335-3028-7) 15 tablet2026-02-05NoNoHistorical
71335-3028-87133530280820 TABLET in 1 BOTTLE (71335-3028-8) 20 tablet2026-02-05NoNoHistorical