Clonidine Hydrochloride

Product NDC
0904-7443
11-digit product format
009047443
Labeler code
0904
Product ID
0904-7443_7edda115-1bfd-4d8c-a3cd-2c8492ba56cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077901
Marketing category
ANDA
Marketing start
2025-11-21
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.2 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.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173, 884185

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
0904-7443-61Clonidine Hydrochloride100 in 1 CARTONTABLET1003
0904-7443-61Clonidine Hydrochloride1 in 1 BLISTER PACKTABLET13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN8171776a-dd14-4dcc-8860-3c27d8ea95043
884185cloNIDine HCl 0.2 MG Oral TabletPSN8171776a-dd14-4dcc-8860-3c27d8ea95043
884173clonidine hydrochloride 0.1 MG Oral TabletSCD8171776a-dd14-4dcc-8860-3c27d8ea95043
884185clonidine hydrochloride 0.2 MG Oral TabletSCD8171776a-dd14-4dcc-8860-3c27d8ea95043
884173clonidine HCl 100 MCG Oral TabletSY8171776a-dd14-4dcc-8860-3c27d8ea95043
884185clonidine HCl 200 MCG Oral TabletSY8171776a-dd14-4dcc-8860-3c27d8ea95043

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7443-6100904744361100 BLISTER PACK in 1 CARTON (0904-7443-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2025-11-21NoNoCurrent