FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
50268-192
11-digit product format
502680192
Labeler code
50268
Product ID
50268-192_2b48f750-cd85-40fc-e063-6294a90a0299
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA078895
Marketing category
ANDA
Marketing start
2023-05-30
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, 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
50268-192-11clonidine hydrochloride1 in 1 BLISTER PACKTABLET12
50268-192-15clonidine hydrochloride50 in 1 BOXTABLET502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-192-11EA - Each50268-1921a6476d4-53af-460e-95b1-329ce4f17e3f12023-07-06
50268-192-15EA - Each50268-1929fdc6c4d-ce3e-49d5-a248-ff3c513a35f512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-192CLONIDINE HYDROCHLORIDE TABLET [AVPAK]2Current NDC, 2 package rows20250112_fcebe343-18ad-d4cd-e053-6294a90a72d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNfcebe343-18ad-d4cd-e053-6294a90a72d52
884185cloNIDine HCl 0.2 MG Oral TabletPSNfcebe343-18ad-d4cd-e053-6294a90a72d52
884189cloNIDine HCl 0.3 MG Oral TabletPSNfcebe343-18ad-d4cd-e053-6294a90a72d52
884173clonidine hydrochloride 0.1 MG Oral TabletSCDfcebe343-18ad-d4cd-e053-6294a90a72d52
884185clonidine hydrochloride 0.2 MG Oral TabletSCDfcebe343-18ad-d4cd-e053-6294a90a72d52
884189clonidine hydrochloride 0.3 MG Oral TabletSCDfcebe343-18ad-d4cd-e053-6294a90a72d52
884173clonidine HCl 100 MCG Oral TabletSYfcebe343-18ad-d4cd-e053-6294a90a72d52
884185clonidine HCl 200 MCG Oral TabletSYfcebe343-18ad-d4cd-e053-6294a90a72d52
884189clonidine HCl 300 MCG Oral TabletSYfcebe343-18ad-d4cd-e053-6294a90a72d52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-192-11502680192111 in 1 BLISTER PACKHistorical
50268-192-155026801921550 BLISTER PACK in 1 BOX (50268-192-15) / 1 TABLET in 1 BLISTER PACK (50268-192-11) 50 blister pack2023-05-30NoNoCurrent