FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
50090-7475
11-digit product format
500907475
Labeler code
50090
Product ID
50090-7475_58e289a0-7c26-4b42-bdbe-f24d927de240
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091368
Marketing category
ANDA
Marketing start
2016-05-03
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
50090-7475-0clonidine hydrochloride30 in 1 BOTTLETABLET306
50090-7475-1clonidine hydrochloride60 in 1 BOTTLETABLET606
50090-7475-2clonidine hydrochloride100 in 1 BOTTLETABLET1006
50090-7475-7clonidine hydrochloride90 in 1 BOTTLETABLET906
50090-7475-8clonidine hydrochloride180 in 1 BOTTLETABLET1806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7475-0EA - Each50090-7475bd856c32-efd4-4a78-85e0-a2fde5b473b512025-02-10
50090-7475-1EA - Each50090-7475bff237d9-003c-402e-a611-d4dfad81a8e112025-02-10
50090-7475-2EA - Each50090-7475e0cd493a-f3d1-43ab-bd58-3d8661e5c84d12025-02-10
50090-7475-7EA - Each50090-7475fa770ea6-f4db-4b20-8e8c-d80715f61c9112025-02-10
50090-7475-8EA - Each50090-7475ab873b20-2732-4029-be99-7cce47c8fac112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7475CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, 5 package rows20241222_329382fb-ccf8-488d-a0b2-68ff959a0846.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN329382fb-ccf8-488d-a0b2-68ff959a08466
884173clonidine hydrochloride 0.1 MG Oral TabletSCD329382fb-ccf8-488d-a0b2-68ff959a08466
884173clonidine HCl 100 MCG Oral TabletSY329382fb-ccf8-488d-a0b2-68ff959a08466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7475-05009074750030 TABLET in 1 BOTTLE (50090-7475-0) 30 tablet2024-12-19NoNoCurrent
50090-7475-15009074750160 TABLET in 1 BOTTLE (50090-7475-1) 60 tablet2024-12-19NoNoCurrent
50090-7475-250090747502100 TABLET in 1 BOTTLE (50090-7475-2) 100 tablet2024-12-19NoNoCurrent
50090-7475-75009074750790 TABLET in 1 BOTTLE (50090-7475-7) 90 tablet2024-12-19NoNoCurrent
50090-7475-850090747508180 TABLET in 1 BOTTLE (50090-7475-8) 180 tablet2024-12-19NoNoCurrent