FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
62332-054
11-digit product format
623320054
Labeler code
62332
Product ID
62332-054_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
.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
62332-054-10clonidine hydrochloride100 in 1 CARTONTABLET1006
62332-054-30clonidine hydrochloride30 in 1 BOTTLETABLET306
62332-054-31clonidine hydrochloride100 in 1 BOTTLETABLET1006
62332-054-71clonidine hydrochloride500 in 1 BOTTLETABLET5006
62332-054-91clonidine hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-054-31EA - Each62332-054fd5ff23e-a29b-4cfa-9bf1-4f90fabe5aa712016-06-14
62332-054-71EA - Each62332-05429842fed-6226-4ea0-8f41-1e5b3ecf2ef012016-06-14
62332-054-91EA - Each62332-05495304f2d-ce9e-4e5f-8f56-4caae756361612016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-054CLONIDINE 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
884173cloNIDine HCl 0.1 MG Oral TabletPSN574640a5-829d-4e9d-be32-832a48cbd8dd14
884173cloNIDine HCl 0.1 MG Oral TabletPSN5366a055-47fd-41eb-81d8-ffb3be1dc38c14
884173clonidine hydrochloride 0.1 MG Oral TabletSCD574640a5-829d-4e9d-be32-832a48cbd8dd14
884173clonidine hydrochloride 0.1 MG Oral TabletSCD5366a055-47fd-41eb-81d8-ffb3be1dc38c14
884173clonidine HCl 100 MCG Oral TabletSY574640a5-829d-4e9d-be32-832a48cbd8dd14
884173clonidine HCl 100 MCG Oral TabletSY5366a055-47fd-41eb-81d8-ffb3be1dc38c14
884173cloNIDine HCl 0.1 MG Oral TabletPSNbe6c29cd-1692-4dd3-868e-7efcb3a8505612
884173clonidine hydrochloride 0.1 MG Oral TabletSCDbe6c29cd-1692-4dd3-868e-7efcb3a8505612
884173clonidine HCl 100 MCG Oral TabletSYbe6c29cd-1692-4dd3-868e-7efcb3a8505612
884173cloNIDine HCl 0.1 MG Oral TabletPSN56a80e79-9cfe-4361-a90a-9245632efa0510
884173clonidine hydrochloride 0.1 MG Oral TabletSCD56a80e79-9cfe-4361-a90a-9245632efa0510
884173clonidine HCl 100 MCG Oral TabletSY56a80e79-9cfe-4361-a90a-9245632efa0510
884173cloNIDine HCl 0.1 MG Oral TabletPSN87263d3f-c308-4cf5-ab53-ebb8d145c9008
884185cloNIDine HCl 0.2 MG Oral TabletPSN87263d3f-c308-4cf5-ab53-ebb8d145c9008
884173clonidine hydrochloride 0.1 MG Oral TabletSCD87263d3f-c308-4cf5-ab53-ebb8d145c9008
884185clonidine hydrochloride 0.2 MG Oral TabletSCD87263d3f-c308-4cf5-ab53-ebb8d145c9008
884173clonidine HCl 100 MCG Oral TabletSY87263d3f-c308-4cf5-ab53-ebb8d145c9008
884185clonidine HCl 200 MCG Oral TabletSY87263d3f-c308-4cf5-ab53-ebb8d145c9008
884173cloNIDine HCl 0.1 MG Oral TabletPSNaecd05bf-e7ba-4cab-9494-4ce3bbd1aa997
884173clonidine hydrochloride 0.1 MG Oral TabletSCDaecd05bf-e7ba-4cab-9494-4ce3bbd1aa997
884173clonidine HCl 100 MCG Oral TabletSYaecd05bf-e7ba-4cab-9494-4ce3bbd1aa997
884173cloNIDine HCl 0.1 MG Oral TabletPSN61b56917-1442-4068-86d8-0e5a5a59e6126
884173cloNIDine HCl 0.1 MG Oral TabletPSN329382fb-ccf8-488d-a0b2-68ff959a08466
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 TabletSCD329382fb-ccf8-488d-a0b2-68ff959a08466
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
884173clonidine HCl 100 MCG Oral TabletSY329382fb-ccf8-488d-a0b2-68ff959a08466
884185clonidine HCl 200 MCG Oral TabletSY61b56917-1442-4068-86d8-0e5a5a59e6126
884189clonidine HCl 300 MCG Oral TabletSY61b56917-1442-4068-86d8-0e5a5a59e6126
884173cloNIDine HCl 0.1 MG Oral TabletPSN666e757e-9b43-2e40-e053-2991aa0a59a25
884173clonidine hydrochloride 0.1 MG Oral TabletSCD666e757e-9b43-2e40-e053-2991aa0a59a25
884173clonidine HCl 100 MCG Oral TabletSY666e757e-9b43-2e40-e053-2991aa0a59a25
884173cloNIDine HCl 0.1 MG Oral TabletPSN2823a922-3217-6062-e054-00144ff88e884
884173cloNIDine HCl 0.1 MG Oral TabletPSNa9de8b29-5cd2-a49d-e053-2995a90a4f0e4
884189cloNIDine HCl 0.3 MG Oral TabletPSN2823a922-3217-6062-e054-00144ff88e884
884173clonidine hydrochloride 0.1 MG Oral TabletSCDa9de8b29-5cd2-a49d-e053-2995a90a4f0e4
884173clonidine hydrochloride 0.1 MG Oral TabletSCD2823a922-3217-6062-e054-00144ff88e884
884189clonidine hydrochloride 0.3 MG Oral TabletSCD2823a922-3217-6062-e054-00144ff88e884
884173clonidine HCl 100 MCG Oral TabletSYa9de8b29-5cd2-a49d-e053-2995a90a4f0e4
884173clonidine HCl 100 MCG Oral TabletSY2823a922-3217-6062-e054-00144ff88e884
884189clonidine HCl 300 MCG Oral TabletSY2823a922-3217-6062-e054-00144ff88e884
884173cloNIDine HCl 0.1 MG Oral TabletPSN42788adf-a54d-3545-e063-6394a90a8c691
884173cloNIDine HCl 0.1 MG Oral TabletPSNb60034a6-b8ba-4e54-9ef0-029965e67bc01
884173clonidine hydrochloride 0.1 MG Oral TabletSCD42788adf-a54d-3545-e063-6394a90a8c691
884173clonidine hydrochloride 0.1 MG Oral TabletSCDb60034a6-b8ba-4e54-9ef0-029965e67bc01
884173clonidine HCl 100 MCG Oral TabletSY42788adf-a54d-3545-e063-6394a90a8c691
884173clonidine HCl 100 MCG Oral TabletSYb60034a6-b8ba-4e54-9ef0-029965e67bc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-054-1062332005410100 TABLET in 1 CARTON (62332-054-10) 100 tablet2016-05-030000-00-00NoNoCurrent
62332-054-306233200543030 TABLET in 1 BOTTLE (62332-054-30) 30 tablet2016-05-030000-00-00NoNoCurrent
62332-054-3162332005431100 TABLET in 1 BOTTLE (62332-054-31) 100 tablet2016-05-030000-00-00NoNoCurrent
62332-054-7162332005471500 TABLET in 1 BOTTLE (62332-054-71) 500 tablet2016-05-030000-00-00NoNoCurrent
62332-054-91623320054911000 TABLET in 1 BOTTLE (62332-054-91) 1000 tablet2016-05-030000-00-00NoNoCurrent