FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
60760-057
11-digit product format
607600057
Labeler code
60760
Product ID
60760-057_511927b6-627c-3ac5-e063-6294a90ac2a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA091368
Marketing category
ANDA
Marketing start
2018-03-02
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
60760-057-30clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET305
60760-057-90clonidine hydrochloride90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-057CLONIDINE HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]4Current NDC, Legacy NDC, 2 package rows20200411_666e757e-9b43-2e40-e053-2991aa0a59a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN666e757e-9b43-2e40-e053-2991aa0a59a25
884173clonidine hydrochloride 0.1 MG Oral TabletSCD666e757e-9b43-2e40-e053-2991aa0a59a25
884173clonidine HCl 100 MCG Oral TabletSY666e757e-9b43-2e40-e053-2991aa0a59a25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-057-306076000573030 TABLET in 1 BOTTLE, PLASTIC (60760-057-30) 30 tablet2018-03-020000-00-00NoNoCurrent
60760-057-906076000579090 TABLET in 1 BOTTLE, PLASTIC (60760-057-90) 90 tablet2020-04-100000-00-00NoNoCurrent