FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
53002-4140
11-digit product format
530024140
Labeler code
53002
Product ID
53002-4140_5f654855-e06c-463c-8170-f57b0338e108
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA091368
Marketing category
ANDA
Marketing start
2016-05-03
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
2021-12-31
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
53002-4140-02025-01-30C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
53002-4140-32025-01-30C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
53002-4140-02023-06-07C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
53002-4140-32023-06-07C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
53002-4140-02023-01-30C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
53002-4140-32023-01-30C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
53002-4140-02020-12-17C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
53002-4140-32020-12-17C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
53002-4140-02020-01-31C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
53002-4140-32020-01-31C16284748780-19d75b9d0-e84e-f424-e053-dadaa90a57ceClonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4140-0clonidine hydrochloride100 in 1 BOTTLETABLET1008
53002-4140-3clonidine hydrochloride30 in 1 BOTTLETABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4140CLONIDINE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]8Legacy NDC, 2 package rows20230609_87263d3f-c308-4cf5-ab53-ebb8d145c900.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN87263d3f-c308-4cf5-ab53-ebb8d145c9008
884185cloNIDine HCl 0.2 MG Oral TabletPSN87263d3f-c308-4cf5-ab53-ebb8d145c9008
884173clonidine hydrochloride 0.1 MG Oral TabletSCD87263d3f-c308-4cf5-ab53-ebb8d145c9008
884185clonidine hydrochloride 0.2 MG Oral TabletSCD87263d3f-c308-4cf5-ab53-ebb8d145c9008
884173clonidine HCl 100 MCG Oral TabletSY87263d3f-c308-4cf5-ab53-ebb8d145c9008
884185clonidine HCl 200 MCG Oral TabletSY87263d3f-c308-4cf5-ab53-ebb8d145c9008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4140-053002414000100 TABLET in 1 BOTTLE (53002-4140-0) 100 tablet2018-10-010000-00-00NoNoCurrent
53002-4140-35300241400330 TABLET in 1 BOTTLE (53002-4140-3) 30 tablet2018-10-010000-00-00NoNoCurrent