FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
71335-1624
11-digit product format
713351624
Labeler code
71335
Product ID
71335-1624_33d61efe-5a9c-485f-a687-1a879fa91cbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070923
Marketing category
ANDA
Marketing start
2017-06-01
Marketing end
0000-00-00
Substance
CLONIDINE HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1624-12024-01-30C16284748780-11030e365-3ced-111a-e063-dadaa90a10e2Clonidine hydrochloride
71335-1624-22024-01-30C16284748780-11030e365-3ced-111a-e063-dadaa90a10e2Clonidine hydrochloride
71335-1624-32024-01-30C16284748780-11030e365-3ced-111a-e063-dadaa90a10e2Clonidine hydrochloride
71335-1624-42024-01-30C16284748780-11030e365-3ced-111a-e063-dadaa90a10e2Clonidine hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1624-1Clonidine hydrochloride60 in 1 BOTTLETABLET60100
71335-1624-2Clonidine hydrochloride30 in 1 BOTTLETABLET30100
71335-1624-3Clonidine hydrochloride90 in 1 BOTTLETABLET90100
71335-1624-4Clonidine hydrochloride120 in 1 BOTTLETABLET120100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1624CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Legacy NDC, 4 package rows20220211_f65d90dc-11b4-4d63-b4a9-30603bc332ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884189cloNIDine HCl 0.3 MG Oral TabletPSNf65d90dc-11b4-4d63-b4a9-30603bc332ea100
884189clonidine hydrochloride 0.3 MG Oral TabletSCDf65d90dc-11b4-4d63-b4a9-30603bc332ea100
884189clonidine HCl 300 MCG Oral TabletSYf65d90dc-11b4-4d63-b4a9-30603bc332ea100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1624-17133516240160 TABLET in 1 BOTTLE (71335-1624-1) 60 tablet2020-06-180000-00-00NoNoCurrent
71335-1624-27133516240230 TABLET in 1 BOTTLE (71335-1624-2) 30 tablet2020-06-180000-00-00NoNoCurrent
71335-1624-37133516240390 TABLET in 1 BOTTLE (71335-1624-3) 90 tablet2020-06-180000-00-00NoNoCurrent
71335-1624-471335162404120 TABLET in 1 BOTTLE (71335-1624-4) 120 tablet2020-06-180000-00-00NoNoCurrent