FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
46708-308
11-digit product format
467080308
Labeler code
46708
Product ID
46708-308_f2ae3ce9-d436-4616-a3eb-7838af98b9a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
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
46708-308-10clonidine hydrochloride100 in 1 CARTONTABLET1004
46708-308-30clonidine hydrochloride30 in 1 BOTTLETABLET304
46708-308-31clonidine hydrochloride100 in 1 BOTTLETABLET1004
46708-308-71clonidine hydrochloride500 in 1 BOTTLETABLET5004
46708-308-91clonidine hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-308CLONIDINE HYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 5 package rows20230129_88a8db46-0fc9-48cd-b7cc-ac9c9cdea100.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN88a8db46-0fc9-48cd-b7cc-ac9c9cdea1004
884185cloNIDine HCl 0.2 MG Oral TabletPSN88a8db46-0fc9-48cd-b7cc-ac9c9cdea1004
884189cloNIDine HCl 0.3 MG Oral TabletPSN88a8db46-0fc9-48cd-b7cc-ac9c9cdea1004
884173clonidine hydrochloride 0.1 MG Oral TabletSCD88a8db46-0fc9-48cd-b7cc-ac9c9cdea1004
884185clonidine hydrochloride 0.2 MG Oral TabletSCD88a8db46-0fc9-48cd-b7cc-ac9c9cdea1004
884189clonidine hydrochloride 0.3 MG Oral TabletSCD88a8db46-0fc9-48cd-b7cc-ac9c9cdea1004
884173clonidine HCl 100 MCG Oral TabletSY88a8db46-0fc9-48cd-b7cc-ac9c9cdea1004
884185clonidine HCl 200 MCG Oral TabletSY88a8db46-0fc9-48cd-b7cc-ac9c9cdea1004
884189clonidine HCl 300 MCG Oral TabletSY88a8db46-0fc9-48cd-b7cc-ac9c9cdea1004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-308-1046708030810100 TABLET in 1 CARTON (46708-308-10) 100 tablet2016-05-030000-00-00NoNoCurrent
46708-308-304670803083030 TABLET in 1 BOTTLE (46708-308-30) 30 tablet2016-05-030000-00-00NoNoCurrent
46708-308-3146708030831100 TABLET in 1 BOTTLE (46708-308-31) 100 tablet2016-05-030000-00-00NoNoCurrent
46708-308-7146708030871500 TABLET in 1 BOTTLE (46708-308-71) 500 tablet2016-05-030000-00-00NoNoCurrent
46708-308-91467080308911000 TABLET in 1 BOTTLE (46708-308-91) 1000 tablet2016-05-030000-00-00NoNoCurrent