FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
68071-4661
11-digit product format
680714661
Labeler code
68071
Product ID
68071-4661_2bed1bae-519d-1bb9-e063-6294a90a795b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA070974
Marketing category
ANDA
Marketing start
1995-01-03
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4661-92024-06-12C16284748780-1ba0f9c33-4569-a910-e053-dadaa90a0b85CLONIDINE HYDROCHLORIDE TABLETS, USP
68071-4661-92023-01-30C16284748780-1ba0f9c33-4569-a910-e053-dadaa90a0b85CLONIDINE HYDROCHLORIDE TABLETS, USP
68071-4661-92021-02-17C16284748780-1ba0f9c33-4569-a910-e053-dadaa90a0b85CLONIDINE HYDROCHLORIDE TABLETS, USP
68071-4661-92021-01-29C16284748780-1ba0f9c33-4569-a910-e053-dadaa90a0b85CLONIDINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4661-2Clonidine Hydrochloride120 in 1 BOTTLETABLET1206
68071-4661-9Clonidine Hydrochloride90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4661CLONIDINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 2 package rows20250119_7cd64137-09d7-7a00-e053-2a91aa0a06ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN7cd64137-09d7-7a00-e053-2a91aa0a06ae6
884173clonidine hydrochloride 0.1 MG Oral TabletSCD7cd64137-09d7-7a00-e053-2a91aa0a06ae6
884173clonidine HCl 100 MCG Oral TabletSY7cd64137-09d7-7a00-e053-2a91aa0a06ae6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4661-268071466102120 TABLET in 1 BOTTLE (68071-4661-2) 120 tablet2025-01-17NoNoCurrent
68071-4661-96807146610990 TABLET in 1 BOTTLE (68071-4661-9) 90 tablet2018-12-120000-00-00NoNoCurrent