FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
63629-1208
11-digit product format
636291208
Labeler code
63629
Product ID
63629-1208_bd8186d6-46d1-41e6-9b8c-f8600d843aa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209757
Marketing category
ANDA
Marketing start
2018-02-15
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
Rxcui1013930

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
63629-1208-1Clonidine Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE60103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1208CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240719_9fb36ee3-3d93-4c2e-b399-691305bac715.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSN9fb36ee3-3d93-4c2e-b399-691305bac715103
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCD9fb36ee3-3d93-4c2e-b399-691305bac715103
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSY9fb36ee3-3d93-4c2e-b399-691305bac715103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1208-16362912080160 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1208-1) 2024-07-080000-00-00NoNoCurrent