FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
71335-2489
11-digit product format
713352489
Labeler code
71335
Product ID
71335-2489_a121099c-05a7-4722-b2e2-71eacbfa4cdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202297
Marketing category
ANDA
Marketing start
2020-07-01
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
71335-2489-0Clonidine Hydrochloride24 in 1 BOTTLETABLET241
71335-2489-1Clonidine Hydrochloride100 in 1 BOTTLETABLET1001
71335-2489-2Clonidine Hydrochloride30 in 1 BOTTLETABLET301
71335-2489-3Clonidine Hydrochloride20 in 1 BOTTLETABLET201
71335-2489-4Clonidine Hydrochloride60 in 1 BOTTLETABLET601
71335-2489-5Clonidine Hydrochloride120 in 1 BOTTLETABLET1201
71335-2489-6Clonidine Hydrochloride90 in 1 BOTTLETABLET901
71335-2489-7Clonidine Hydrochloride10 in 1 BOTTLETABLET101
71335-2489-8Clonidine Hydrochloride45 in 1 BOTTLETABLET451
71335-2489-9Clonidine Hydrochloride14 in 1 BOTTLETABLET141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2489CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 10 package rows20240920_1c65bafb-9752-4785-84b1-376cf863fd07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN1c65bafb-9752-4785-84b1-376cf863fd071
884173clonidine hydrochloride 0.1 MG Oral TabletSCD1c65bafb-9752-4785-84b1-376cf863fd071
884173clonidine HCl 100 MCG Oral TabletSY1c65bafb-9752-4785-84b1-376cf863fd071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2489-07133524890024 TABLET in 1 BOTTLE (71335-2489-0) 24 tablet2024-09-18NoNoHistorical
71335-2489-171335248901100 TABLET in 1 BOTTLE (71335-2489-1) 100 tablet2024-09-18NoNoHistorical
71335-2489-27133524890230 TABLET in 1 BOTTLE (71335-2489-2) 30 tablet2024-09-18NoNoHistorical
71335-2489-37133524890320 TABLET in 1 BOTTLE (71335-2489-3) 20 tablet2024-09-18NoNoHistorical
71335-2489-47133524890460 TABLET in 1 BOTTLE (71335-2489-4) 60 tablet2024-09-18NoNoHistorical
71335-2489-571335248905120 TABLET in 1 BOTTLE (71335-2489-5) 120 tablet2024-09-18NoNoHistorical
71335-2489-67133524890690 TABLET in 1 BOTTLE (71335-2489-6) 90 tablet2024-09-18NoNoHistorical
71335-2489-77133524890710 TABLET in 1 BOTTLE (71335-2489-7) 10 tablet2024-09-18NoNoHistorical
71335-2489-87133524890845 TABLET in 1 BOTTLE (71335-2489-8) 45 tablet2024-09-18NoNoHistorical
71335-2489-97133524890914 TABLET in 1 BOTTLE (71335-2489-9) 14 tablet2024-09-18NoNoHistorical