FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
71335-0777
11-digit product format
713350777
Labeler code
71335
Product ID
71335-0777_bc883971-73e7-43b2-8b10-840c87eaa79e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091368
Marketing category
ANDA
Marketing start
2016-05-03
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
clonidine hydrochloride
Listing expiration
2026-12-31

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
71335-0777-0clonidine hydrochloride24 in 1 BOTTLETABLET2412
71335-0777-1clonidine hydrochloride100 in 1 BOTTLETABLET10012
71335-0777-2clonidine hydrochloride30 in 1 BOTTLETABLET3012
71335-0777-3clonidine hydrochloride20 in 1 BOTTLETABLET2012
71335-0777-4clonidine hydrochloride60 in 1 BOTTLETABLET6012
71335-0777-5clonidine hydrochloride120 in 1 BOTTLETABLET12012
71335-0777-6clonidine hydrochloride90 in 1 BOTTLETABLET9012
71335-0777-7clonidine hydrochloride10 in 1 BOTTLETABLET1012
71335-0777-8clonidine hydrochloride45 in 1 BOTTLETABLET4512
71335-0777-9clonidine hydrochloride14 in 1 BOTTLETABLET1412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0777-1EA - Each71335-077791994d12-c562-437f-b9ce-2ee6dac9928312022-09-12
71335-0777-2EA - Each71335-07776cf26e14-2bfc-4be0-970d-e57c8da9b5ef12024-11-05
71335-0777-6EA - Each71335-0777aa52d37c-2784-4945-a602-16570be7db8c12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0777CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 10 package rows20240824_be6c29cd-1692-4dd3-868e-7efcb3a85056.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNbe6c29cd-1692-4dd3-868e-7efcb3a8505612
884173clonidine hydrochloride 0.1 MG Oral TabletSCDbe6c29cd-1692-4dd3-868e-7efcb3a8505612
884173clonidine HCl 100 MCG Oral TabletSYbe6c29cd-1692-4dd3-868e-7efcb3a8505612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0777-07133507770024 TABLET in 1 BOTTLE (71335-0777-0) 24 tablet2021-12-270000-00-00NoNoCurrent
71335-0777-171335077701100 TABLET in 1 BOTTLE (71335-0777-1) 100 tablet2018-04-270000-00-00NoNoCurrent
71335-0777-27133507770230 TABLET in 1 BOTTLE (71335-0777-2) 30 tablet2018-04-160000-00-00NoNoCurrent
71335-0777-37133507770320 TABLET in 1 BOTTLE (71335-0777-3) 20 tablet2021-04-210000-00-00NoNoCurrent
71335-0777-47133507770460 TABLET in 1 BOTTLE (71335-0777-4) 60 tablet2018-07-300000-00-00NoNoCurrent
71335-0777-571335077705120 TABLET in 1 BOTTLE (71335-0777-5) 120 tablet2018-04-120000-00-00NoNoCurrent
71335-0777-67133507770690 TABLET in 1 BOTTLE (71335-0777-6) 90 tablet2018-04-200000-00-00NoNoCurrent
71335-0777-77133507770710 TABLET in 1 BOTTLE (71335-0777-7) 10 tablet2021-04-130000-00-00NoNoCurrent
71335-0777-87133507770845 TABLET in 1 BOTTLE (71335-0777-8) 45 tablet2021-12-270000-00-00NoNoCurrent
71335-0777-97133507770914 TABLET in 1 BOTTLE (71335-0777-9) 14 tablet2021-01-260000-00-00NoNoCurrent