FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
50090-1910
11-digit product format
500901910
Labeler code
50090
Product ID
50090-1910_a1e2050a-9fa4-4553-b069-5e83ec86bdb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078895
Marketing category
ANDA
Marketing start
2009-09-21
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1910-02023-02-07C16284748780-1f386c649-c696-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-1910-12023-02-07C16284748780-1f386c649-c696-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-1910-02023-01-30C16284748780-1f386c649-c696-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-1910-12023-01-30C16284748780-1f386c649-c696-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1910-0clonidine hydrochloride100 in 1 BOTTLETABLET10030
50090-1910-1clonidine hydrochloride60 in 1 BOTTLETABLET6030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1910-1EA - Each50090-1910277c46cb-a26f-4186-b1b8-222c101a8ff812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1910CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]30Current NDC, Legacy NDC, 2 package rows20240906_70c0c9f4-075d-4621-ae13-e8f03d814d5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884185cloNIDine HCl 0.2 MG Oral TabletPSN70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189cloNIDine HCl 0.3 MG Oral TabletPSN70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884173clonidine hydrochloride 0.1 MG Oral TabletSCD70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884185clonidine hydrochloride 0.2 MG Oral TabletSCD70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189clonidine hydrochloride 0.3 MG Oral TabletSCD70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884173clonidine HCl 100 MCG Oral TabletSY70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884185clonidine HCl 200 MCG Oral TabletSY70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189clonidine HCl 300 MCG Oral TabletSY70c0c9f4-075d-4621-ae13-e8f03d814d5f30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1910-050090191000100 TABLET in 1 BOTTLE (50090-1910-0) 100 tablet2018-11-010000-00-00NoNoCurrent
50090-1910-15009019100160 TABLET in 1 BOTTLE (50090-1910-1) 60 tablet2015-06-290000-00-00NoNoCurrent