FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
50090-5577
11-digit product format
500905577
Labeler code
50090
Product ID
50090-5577_fdd69294-31b5-4a0f-9c9c-210ce908110c
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
2020-12-24
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 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.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173

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
50090-5577-02023-02-06C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-5577-12023-02-06C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-5577-22023-02-06C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-5577-72023-02-06C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-5577-82023-02-06C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-5577-02023-01-30C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-5577-12023-01-30C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-5577-22023-01-30C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-5577-72023-01-30C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP
50090-5577-82023-01-30C16284748780-1f386c64a-3a75-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5577-0clonidine hydrochloride30 in 1 BOTTLETABLET3026
50090-5577-1clonidine hydrochloride60 in 1 BOTTLETABLET6026
50090-5577-2clonidine hydrochloride100 in 1 BOTTLETABLET10026
50090-5577-7clonidine hydrochloride90 in 1 BOTTLETABLET9026
50090-5577-8clonidine hydrochloride180 in 1 BOTTLETABLET18026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5577CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]26Current NDC, Legacy NDC, 5 package rows20241010_9d889b1c-9599-44fa-9e47-6261fbf2837e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN9d889b1c-9599-44fa-9e47-6261fbf2837e26
884173clonidine hydrochloride 0.1 MG Oral TabletSCD9d889b1c-9599-44fa-9e47-6261fbf2837e26
884173clonidine HCl 100 MCG Oral TabletSY9d889b1c-9599-44fa-9e47-6261fbf2837e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5577-05009055770030 TABLET in 1 BOTTLE (50090-5577-0) 30 tablet2021-07-020000-00-00NoNoCurrent
50090-5577-15009055770160 TABLET in 1 BOTTLE (50090-5577-1) 60 tablet2021-07-020000-00-00NoNoCurrent
50090-5577-250090557702100 TABLET in 1 BOTTLE (50090-5577-2) 100 tablet2021-07-020000-00-00NoNoCurrent
50090-5577-75009055770790 TABLET in 1 BOTTLE (50090-5577-7) 90 tablet2021-07-020000-00-00NoNoCurrent
50090-5577-850090557708180 TABLET in 1 BOTTLE (50090-5577-8) 180 tablet2021-07-020000-00-00NoNoCurrent