FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
59651-234
11-digit product format
596510234
Labeler code
59651
Product ID
59651-234_2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA070886
Marketing category
ANDA
Marketing start
2021-06-02
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
Rxcui884173, 884185, 884189

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
59651-234-01Clonidine Hydrochloride100 in 1 BOTTLETABLET1001
59651-234-05Clonidine Hydrochloride500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-234-01EA - Each59651-234e43ecdb6-c252-402f-aa57-a897672cee8712023-04-07
59651-234-05EA - Each59651-2344309ebd4-b396-447a-84b0-c2520b08620d12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-234CLONIDINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 2 package rows20220609_2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884189cloNIDine HCl 0.3 MG Oral TabletPSNc8e151d6-50c6-47a1-80b0-bd8e07acddd2100
884189clonidine hydrochloride 0.3 MG Oral TabletSCDc8e151d6-50c6-47a1-80b0-bd8e07acddd2100
884189clonidine HCl 300 MCG Oral TabletSYc8e151d6-50c6-47a1-80b0-bd8e07acddd2100
884173cloNIDine HCl 0.1 MG Oral TabletPSN2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb1
884185cloNIDine HCl 0.2 MG Oral TabletPSN2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb1
884189cloNIDine HCl 0.3 MG Oral TabletPSN1e1a8eb9-6e0b-9e87-e063-6394a90ad18e1
884189cloNIDine HCl 0.3 MG Oral TabletPSN2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb1
884173clonidine hydrochloride 0.1 MG Oral TabletSCD2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb1
884185clonidine hydrochloride 0.2 MG Oral TabletSCD2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb1
884189clonidine hydrochloride 0.3 MG Oral TabletSCD1e1a8eb9-6e0b-9e87-e063-6394a90ad18e1
884189clonidine hydrochloride 0.3 MG Oral TabletSCD2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb1
884173clonidine HCl 100 MCG Oral TabletSY2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb1
884185clonidine HCl 200 MCG Oral TabletSY2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb1
884189clonidine HCl 300 MCG Oral TabletSY1e1a8eb9-6e0b-9e87-e063-6394a90ad18e1
884189clonidine HCl 300 MCG Oral TabletSY2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-234-0159651023401100 TABLET in 1 BOTTLE (59651-234-01) 100 tablet2021-06-020000-00-00NoNoCurrent
59651-234-0559651023405500 TABLET in 1 BOTTLE (59651-234-05) 500 tablet2021-06-020000-00-00NoNoCurrent