FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
71335-0915
11-digit product format
713350915
Labeler code
71335
Product ID
71335-0915_66ef8c67-ef10-4df2-875c-4d9d268930d2
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
.3 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.3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884189

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
71335-0915-1clonidine hydrochloride60 in 1 BOTTLETABLET60102
71335-0915-2clonidine hydrochloride30 in 1 BOTTLETABLET30102
71335-0915-3clonidine hydrochloride90 in 1 BOTTLETABLET90102
71335-0915-4clonidine hydrochloride120 in 1 BOTTLETABLET120102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0915CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20250331_1c13555e-acfc-4a3a-93cd-e6f012f36c61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884189cloNIDine HCl 0.3 MG Oral TabletPSN1c13555e-acfc-4a3a-93cd-e6f012f36c61102
884189clonidine hydrochloride 0.3 MG Oral TabletSCD1c13555e-acfc-4a3a-93cd-e6f012f36c61102
884189clonidine HCl 300 MCG Oral TabletSY1c13555e-acfc-4a3a-93cd-e6f012f36c61102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0915-17133509150160 TABLET in 1 BOTTLE (71335-0915-1) 60 tablet2022-02-090000-00-00NoNoCurrent
71335-0915-27133509150230 TABLET in 1 BOTTLE (71335-0915-2) 30 tablet2022-02-090000-00-00NoNoCurrent
71335-0915-37133509150390 TABLET in 1 BOTTLE (71335-0915-3) 90 tablet2022-02-090000-00-00NoNoCurrent
71335-0915-471335091504120 TABLET in 1 BOTTLE (71335-0915-4) 120 tablet2022-02-090000-00-00NoNoCurrent