FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
68788-7145
11-digit product format
687887145
Labeler code
68788
Product ID
68788-7145_a81c5dd1-2063-410e-aae4-4fdce7c122dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091368
Marketing category
ANDA
Marketing start
2018-04-23
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
68788-7145-1clonidine hydrochloride100 in 1 BOTTLETABLET10010
68788-7145-3clonidine hydrochloride30 in 1 BOTTLETABLET3010
68788-7145-6clonidine hydrochloride60 in 1 BOTTLETABLET6010
68788-7145-9clonidine hydrochloride90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7145-1EA - Each68788-714581b8646b-226c-4032-96aa-ee5296cbee4412018-06-11
68788-7145-3EA - Each68788-7145613622ba-7802-4b8a-abab-4d2ef859829312018-06-11
68788-7145-6EA - Each68788-7145b2435272-ebfe-427f-8b50-c6d76f9a272d12018-06-11
68788-7145-9EA - Each68788-7145bc483f62-9bf1-4614-bd9e-6c3fcc500b0112018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7145CLONIDINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 4 package rows20250309_56a80e79-9cfe-4361-a90a-9245632efa05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN56a80e79-9cfe-4361-a90a-9245632efa0510
884173clonidine hydrochloride 0.1 MG Oral TabletSCD56a80e79-9cfe-4361-a90a-9245632efa0510
884173clonidine HCl 100 MCG Oral TabletSY56a80e79-9cfe-4361-a90a-9245632efa0510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7145-168788714501100 TABLET in 1 BOTTLE (68788-7145-1) 100 tablet2018-04-230000-00-00NoNoCurrent
68788-7145-36878871450330 TABLET in 1 BOTTLE (68788-7145-3) 30 tablet2018-04-230000-00-00NoNoCurrent
68788-7145-66878871450660 TABLET in 1 BOTTLE (68788-7145-6) 60 tablet2018-04-230000-00-00NoNoCurrent
68788-7145-96878871450990 TABLET in 1 BOTTLE (68788-7145-9) 90 tablet2018-04-230000-00-00NoNoCurrent