FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
60760-992
11-digit product format
607600992
Labeler code
60760
Product ID
60760-992_4f7061f2-591f-ddf8-e063-6394a90a5d87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA078895
Marketing category
ANDA
Marketing start
2020-12-24
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
60760-992-30clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
60760-992-90clonidine hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-992CLONIDINE HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 2 package rows20250424_32d72d7b-5881-f431-e063-6394a90a3547.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN32d72d7b-5881-f431-e063-6394a90a35472
884173clonidine hydrochloride 0.1 MG Oral TabletSCD32d72d7b-5881-f431-e063-6394a90a35472
884173clonidine HCl 100 MCG Oral TabletSY32d72d7b-5881-f431-e063-6394a90a35472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-992-306076009923030 TABLET in 1 BOTTLE, PLASTIC (60760-992-30) 30 tablet2025-04-15NoNoCurrent
60760-992-906076009929090 TABLET in 1 BOTTLE, PLASTIC (60760-992-90) 90 tablet2026-04-10NoNoCurrent