clonidine hydrochloride

Product NDC
68788-8080
11-digit product format
687888080
Labeler code
68788
Product ID
68788-8080_d3ec9424-482b-4948-8e5e-bb48ac4bca49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091368
Marketing category
ANDA
Marketing start
2021-10-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
clonidine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884185

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
68788-8080-3clonidine hydrochloride30 in 1 BOTTLETABLET305
68788-8080-6clonidine hydrochloride60 in 1 BOTTLETABLET605
68788-8080-9clonidine hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8080-3EA - Each68788-8080ac08eb76-51de-4c36-9b20-078f718ab3f412021-11-09
68788-8080-6EA - Each68788-80806b68b3a1-d69e-46a4-8ba7-b0124049ab9112021-11-09
68788-8080-9EA - Each68788-8080502e9b94-159d-4b15-9b3f-c6ed39f798bf12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8080CLONIDINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20250112_770b56aa-fcf3-4327-98d1-d87e5a037234.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSN770b56aa-fcf3-4327-98d1-d87e5a0372345
884185clonidine hydrochloride 0.2 MG Oral TabletSCD770b56aa-fcf3-4327-98d1-d87e5a0372345
884185clonidine HCl 200 MCG Oral TabletSY770b56aa-fcf3-4327-98d1-d87e5a0372345

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8080-36878880800330 TABLET in 1 BOTTLE (68788-8080-3) 30 tablet2021-10-050000-00-00NoNoCurrent
68788-8080-66878880800660 TABLET in 1 BOTTLE (68788-8080-6) 60 tablet2021-10-050000-00-00NoNoCurrent
68788-8080-96878880800990 TABLET in 1 BOTTLE (68788-8080-9) 90 tablet2021-10-050000-00-00NoNoCurrent