FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
68788-8494
11-digit product format
687888494
Labeler code
68788
Product ID
68788-8494_8b969475-0adb-40fd-8af7-4a762fd8c172
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078895
Marketing category
ANDA
Marketing start
2023-07-26
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
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.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173

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
68788-8494-1clonidine hydrochloride100 in 1 BOTTLE, PLASTICTABLET1004
68788-8494-3clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET304
68788-8494-6clonidine hydrochloride60 in 1 BOTTLE, PLASTICTABLET604
68788-8494-9clonidine hydrochloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8494-1EA - Each68788-8494940da5b9-c2af-4a7a-b749-dd9150e14c7b12023-09-05
68788-8494-3EA - Each68788-8494046b8839-e740-46e8-b020-8527ba4caa1412023-09-05
68788-8494-6EA - Each68788-8494cf2f4337-9609-455b-a3d7-ae0469af07a412023-09-05
68788-8494-9EA - Each68788-84941509476a-44ed-42cb-a787-48d0ed9e130512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8494CLONIDINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250309_55ab721b-7b4c-42d5-99e3-745008fe139c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN55ab721b-7b4c-42d5-99e3-745008fe139c4
884173clonidine hydrochloride 0.1 MG Oral TabletSCD55ab721b-7b4c-42d5-99e3-745008fe139c4
884173clonidine HCl 100 MCG Oral TabletSY55ab721b-7b4c-42d5-99e3-745008fe139c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8494-168788849401100 TABLET in 1 BOTTLE, PLASTIC (68788-8494-1) 100 tablet2023-07-26NoNoHistorical
68788-8494-36878884940330 TABLET in 1 BOTTLE, PLASTIC (68788-8494-3) 30 tablet2023-07-26NoNoHistorical
68788-8494-66878884940660 TABLET in 1 BOTTLE, PLASTIC (68788-8494-6) 60 tablet2023-07-26NoNoHistorical
68788-8494-96878884940990 TABLET in 1 BOTTLE, PLASTIC (68788-8494-9) 90 tablet2023-07-26NoNoHistorical