FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
50090-6744
11-digit product format
500906744
Labeler code
50090
Product ID
50090-6744_cce6ef3b-e6ae-44e3-9ff1-3e6314e148c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA070886
Marketing category
ANDA
Marketing start
2021-06-02
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6744-0Clonidine Hydrochloride30 in 1 BOTTLETABLET306
50090-6744-1Clonidine Hydrochloride60 in 1 BOTTLETABLET606
50090-6744-2Clonidine Hydrochloride100 in 1 BOTTLETABLET1006
50090-6744-7Clonidine Hydrochloride90 in 1 BOTTLETABLET906
50090-6744-8Clonidine Hydrochloride180 in 1 BOTTLETABLET1806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6744-1EA - Each50090-6744273ee024-63c6-4e5f-a4f3-e9d6a63317c212023-12-05
50090-6744-2EA - Each50090-674492f79324-d8bb-4a2a-b480-c6ae20785ba112023-12-05
50090-6744-7EA - Each50090-674459ce5974-e0a6-4178-9372-db8a3cde502f12023-12-05
50090-6744-8EA - Each50090-6744a6a4714b-896b-4046-b044-2f3c10e4f82512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6744CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, 5 package rows20241009_c7f473df-94ab-41db-8cc7-9a159d5e6dc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNc7f473df-94ab-41db-8cc7-9a159d5e6dc46
884173clonidine hydrochloride 0.1 MG Oral TabletSCDc7f473df-94ab-41db-8cc7-9a159d5e6dc46
884173clonidine HCl 100 MCG Oral TabletSYc7f473df-94ab-41db-8cc7-9a159d5e6dc46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6744-05009067440030 TABLET in 1 BOTTLE (50090-6744-0) 30 tablet2023-10-16NoNoCurrent
50090-6744-15009067440160 TABLET in 1 BOTTLE (50090-6744-1) 60 tablet2023-10-16NoNoCurrent
50090-6744-250090674402100 TABLET in 1 BOTTLE (50090-6744-2) 100 tablet2023-10-16NoNoCurrent
50090-6744-75009067440790 TABLET in 1 BOTTLE (50090-6744-7) 90 tablet2023-10-16NoNoCurrent
50090-6744-850090674408180 TABLET in 1 BOTTLE (50090-6744-8) 180 tablet2023-10-16NoNoCurrent