Clonidine Hydrochloride

Product NDC
53002-4141
11-digit product format
530024141
Labeler code
53002
Product ID
53002-4141_e14d8d07-4a6b-4417-8bd9-f1b5c4b3b9ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA070974
Marketing category
ANDA
Marketing start
1995-01-03
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4141-0Clonidine Hydrochloride100 in 1 BOTTLETABLET1003
53002-4141-3Clonidine Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4141CLONIDINE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_531eb107-a0bf-4346-946c-18715ca22518.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN531eb107-a0bf-4346-946c-18715ca225183
884173clonidine hydrochloride 0.1 MG Oral TabletSCD531eb107-a0bf-4346-946c-18715ca225183
884173clonidine HCl 100 MCG Oral TabletSY531eb107-a0bf-4346-946c-18715ca225183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4141-053002414100100 TABLET in 1 BOTTLE (53002-4141-0) 100 tablet2019-01-010000-00-00NoNoCurrent
53002-4141-35300241410330 TABLET in 1 BOTTLE (53002-4141-3) 30 tablet2019-01-010000-00-00NoNoCurrent