FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
62332-056
11-digit product format
623320056
Labeler code
62332
Product ID
62332-056_100955f8-68c5-437e-9710-8546164e8735
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA091368
Marketing category
ANDA
Marketing start
2016-05-03
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.3 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.3 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
62332-056-10clonidine hydrochloride100 in 1 CARTONTABLET1006
62332-056-30clonidine hydrochloride30 in 1 BOTTLETABLET306
62332-056-31clonidine hydrochloride100 in 1 BOTTLETABLET1006
62332-056-71clonidine hydrochloride500 in 1 BOTTLETABLET5006
62332-056-91clonidine hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-056-31EA - Each62332-056ef16eafc-7a31-4feb-ac6c-837f6068cae112016-06-14
62332-056-71EA - Each62332-056dd5e2edb-32a9-414c-a734-fb4a24286d9f12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-056CLONIDINE HYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 5 package rows20250124_61b56917-1442-4068-86d8-0e5a5a59e612.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884189cloNIDine HCl 0.3 MG Oral TabletPSN1c13555e-acfc-4a3a-93cd-e6f012f36c61102
884189clonidine hydrochloride 0.3 MG Oral TabletSCD1c13555e-acfc-4a3a-93cd-e6f012f36c61102
884189clonidine HCl 300 MCG Oral TabletSY1c13555e-acfc-4a3a-93cd-e6f012f36c61102
884189cloNIDine HCl 0.3 MG Oral TabletPSN3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d67
884189clonidine hydrochloride 0.3 MG Oral TabletSCD3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d67
884189clonidine HCl 300 MCG Oral TabletSY3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d67
884173cloNIDine HCl 0.1 MG Oral TabletPSN61b56917-1442-4068-86d8-0e5a5a59e6126
884185cloNIDine HCl 0.2 MG Oral TabletPSN61b56917-1442-4068-86d8-0e5a5a59e6126
884189cloNIDine HCl 0.3 MG Oral TabletPSN61b56917-1442-4068-86d8-0e5a5a59e6126
884173clonidine hydrochloride 0.1 MG Oral TabletSCD61b56917-1442-4068-86d8-0e5a5a59e6126
884185clonidine hydrochloride 0.2 MG Oral TabletSCD61b56917-1442-4068-86d8-0e5a5a59e6126
884189clonidine hydrochloride 0.3 MG Oral TabletSCD61b56917-1442-4068-86d8-0e5a5a59e6126
884173clonidine HCl 100 MCG Oral TabletSY61b56917-1442-4068-86d8-0e5a5a59e6126
884185clonidine HCl 200 MCG Oral TabletSY61b56917-1442-4068-86d8-0e5a5a59e6126
884189clonidine HCl 300 MCG Oral TabletSY61b56917-1442-4068-86d8-0e5a5a59e6126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-056-1062332005610100 TABLET in 1 CARTON (62332-056-10) 100 tablet2016-05-030000-00-00NoNoCurrent
62332-056-306233200563030 TABLET in 1 BOTTLE (62332-056-30) 30 tablet2016-05-030000-00-00NoNoCurrent
62332-056-3162332005631100 TABLET in 1 BOTTLE (62332-056-31) 100 tablet2016-05-030000-00-00NoNoCurrent
62332-056-7162332005671500 TABLET in 1 BOTTLE (62332-056-71) 500 tablet2016-05-030000-00-00NoNoCurrent
62332-056-91623320056911000 TABLET in 1 BOTTLE (62332-056-91) 1000 tablet2016-05-030000-00-00NoNoCurrent