FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
68788-8163
11-digit product format
687888163
Labeler code
68788
Product ID
68788-8163_07e69323-0b0e-48fc-bff7-354655d52f26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091368
Marketing category
ANDA
Marketing start
2022-04-04
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
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.3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884189

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
68788-8163-1clonidine hydrochloride100 in 1 BOTTLETABLET1007
68788-8163-3clonidine hydrochloride30 in 1 BOTTLETABLET307
68788-8163-6clonidine hydrochloride60 in 1 BOTTLETABLET607
68788-8163-9clonidine hydrochloride90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8163-1EA - Each68788-8163ab39c73c-3193-4d4f-a646-5b151e3ff50812022-05-04
68788-8163-3EA - Each68788-8163431f1320-1fa6-4cfa-9e1d-542fd196a3bd12022-05-04
68788-8163-6EA - Each68788-8163a0fe964a-ed54-4689-87a7-d0d62aad03c112022-05-04
68788-8163-9EA - Each68788-8163d5207513-f1a0-4b16-bc87-1c040c9c3cbc12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8163CLONIDINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20250309_3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884189cloNIDine HCl 0.3 MG Oral TabletPSN3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d67
884189clonidine hydrochloride 0.3 MG Oral TabletSCD3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d67
884189clonidine HCl 300 MCG Oral TabletSY3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8163-168788816301100 TABLET in 1 BOTTLE (68788-8163-1) 100 tablet2022-04-040000-00-00NoNoCurrent
68788-8163-36878881630330 TABLET in 1 BOTTLE (68788-8163-3) 30 tablet2022-04-040000-00-00NoNoCurrent
68788-8163-66878881630660 TABLET in 1 BOTTLE (68788-8163-6) 60 tablet2022-04-040000-00-00NoNoCurrent
68788-8163-96878881630990 TABLET in 1 BOTTLE (68788-8163-9) 90 tablet2022-04-040000-00-00NoNoCurrent